Job Description: Job title Associate – Regulatory Affairs Reports to Senior Associate/Astt Manager/Manager – Regulatory Affairs Job purpose: To carry out Regulatory Review and Compilation of Technical documentation & dossiers for Various Markets in compliance to applicable regulations and guidelines. Duties and responsibilities: • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents, for regulatory filings in emerging markets, for DDReg clients • Assist in development of high quality dossier for various markets • Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier compilation. • Closure of comments with the cross functional team & review of additional data generated in response to review comments per country. • Compilation of Dossier. • Review of registration dossier (m1-m5) as per country specific regulatory requirements • Deficiencies response management from various authorities by coordinating stakeholders for getting documents and compilation and review of response and compile response to queries from the MOH. • Updation of the dossier as per the queries responded (inclusive of all countries) • Demonstrate subject matter and area expertise. • Collaborate with internal and external clients, • Supporting and enabling effective and efficient communication that results in operational excellence. • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites Education & Experience: • Master’s degree in Pharma discipline Knowledge, Skills and Abilities • Excellent technical data interpretation skills • Strong project management skills • Excellent interpersonal skills including problem solving • Strong negotiation skills • Excellent oral and written communication skills with strong presentation skills • Significant knowledge of global, regional, national and other document development guidelines • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. • Great judgment and decision-making skills • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) • Ability and desire to work in a team-oriented environment. • Excellent written and verbal communication skills • Highly proficient with Microsoft Word, PowerPoint and Excel. • Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner • Possesses a collaborative, results-driven style. • Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports: 0 to start with Location: 1. Gurgaon 2. Mumba

Job Description

Job title	Medical-Regulatory Writer – Assistant Manager
Reports to	Director

  Job purpose To plan and Manage Medico-Regulatory Writing for Regulatory in compliance to applicable Regulatory Guidelines Duties and responsibilities

• Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
• Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
• Demonstrate subject matter and therapeutic area expertise.
• Effectively manage medical writing projects to deliver quality products in agreed timelines.
• Collaborate with internal and external clients,
• Writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports and other reports
• Perform science review of aggregate reports produced by PV Associates
• Ensure that document output and processes comply with client specifications, templates and styles guidelines
• Attend project initiation meeting, collate project
• Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
• Maintain & update Aggregate Report Tracker and carry out cases reconciliation on periodic basis
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts
• Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing

Education & Experience

• Master's degree in a Pharmacology/Pharmacy/Medicine
• Advanced degree preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills and Abilities

• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Ability to work under pressure and provide quality outputs within tight timelines

Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports Nil Location Mumbai/ Gurgaon        

Job Description: Job title Medical Writer – Associate/Sr Associate Reports to Director Job purpose: To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to applicable regulatory and Regulatory Guidelines Duties and responsibilities: • Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. • Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices. • Demonstrate subject matter and therapeutic area expertise. • Effectively manage medical writing projects to deliver quality products in agreed timelines. • Collaborate with internal and external clients, • Writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports and other reports • Perform science review of aggregate reports produced by PV Associates • Ensure that document output and processes comply with client specifications, templates and styles guidelines • Attend project initiation meeting, collate project brief. • Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation • Maintain & update Aggregate Report Tracker and carry out cases reconciliation on periodic basis • Supporting and enabling effective and efficient communication that results in operational excellence. • Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts • Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel. Education & Experience: • Master's degree in a Pharmacology/Pharmacy/Medicine • Advanced degree preferred • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience. • Experience working in the pharmaceutical/CRO industry preferred • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous Knowledge, Skills and Abilities • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills • Strong project management skills • Excellent interpersonal skills including problem solving • Strong negotiation skills • Excellent oral and written communication skills with strong presentation skills • Significant knowledge of global, regional, national and other document development guidelines • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. • Great judgment and decision-making skills • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) • Ability and desire to work in a team-oriented environment. • Excellent written and verbal communication skills • Highly proficient with Microsoft Word, PowerPoint and Excel. • Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner • Possesses a collaborative, results-driven style. • Ability to work under pressure and provide quality outputs within tight timelines Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports: Nil Location: Mumbai

Job Description

Job title	Senior Manager/Team Lead – Regulatory Affairs – Regulated Markets
Reports to	Director

  Job purpose To Manage Regulatory Affairs for US Markets in compliance to applicable regulations and guidelines. This position will assist with the preparation and submission of ANDAs, Amendments, Supplements and Annual Reports to appropriate regulatory agencies. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg. Duties and responsibilities

• Providing high-quality CMC review of technical documentation for regulatory filings to US FDA, for DDReg clients
• Actively contribute to the development and implementation of regulatory strategies, processes and timelines for US and global approval.
• Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on US FDA website.
• Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.
• Ensure that draft labeling complies with all applicable regulations and guidelines

Education & Experience

• Bachelor's or Master’s degree in Pharma
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports 1-4 Location Gurgaon, Haryana (INDIA)  

Job Description

Job title	Senior Manager/Team Lead – Regulatory Affairs – Emerging (RoW) Markets
Reports to	Director

  Job purpose To Manage Regulatory Affairs for Emerging (RoW) Markets in compliance to applicable regulations and guidelines. This position will oversee the team of 2-5 team members to manage filings in key RoW markets by DDReg. The responsibility include review of technical documents/dossiers, preparation and submission of Submission dossiers in CTD format, ePublish them (wherever applicable), response to queries, poast approval life cycle management etc. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg. Duties and responsibilities

• Providing high-quality CMC review of technical documentation for regulatory filings to various RoW markets – key market being Saudi & GCC, for DDReg clients
• Actively contribute to the development and implementation of regulatory strategies, processes and timelines for grant of MAs.
• Prepares and compiles new CTD dossiers, renewals and variations ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Efficiently manage team of 2-5 members by way of mentoring them, enhancing & enriching their regulatory knowledge and skill.
• Manage multiple projects with the help of team, track the status of each project, provide update to management in a time bound manner, monitor efficiency of team members.
• Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
• Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.
• Ensure that draft labeling complies with all applicable regulations and guidelines

Education & Experience

• Bachelor's or Master’s degree in Pharma
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports: 2-5 Location Gurgaon, Haryana (INDIA)  

Job Description

Job title	Senior Manager/Team Lead – Regulatory Affairs – Regulated Markets
Reports to	Director

  Job purpose To Manage Regulatory Affairs for EU/Canada/Australia Markets in compliance to applicable regulations and guidelines. This position will assist with the review of CMS documentations, preparation and submission of eCTDs, Variations, site transfers and post approval gap analysis. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg.   Duties and responsibilities  

• Providing high-quality CMC review of technical documentation for regulatory filings to European Medicinal Agency (EMA), UK MHRA, National Agencies of EU Member states, Canada, Australia for DDReg clients
• Running De-centralized Procedures, MRP and procedures for national filings in EU Members states, Health Canada, TGA Australia
• Actively contribute to the development and implementation of regulatory strategies, processes and timelines for EU/UK/Australia/ Canada and global approval.
• Prepares and compiles new CTDs, Variations (Major/Minor/Site Transfers) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the above mentioned agencies, internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website.
• Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.
• Ensure that draft labeling complies with all applicable regulations and guidelines

Education & Experience

• Bachelor's or Master’s degree in Pharma
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred

Knowledge, Skills and Abilities  

• Excellent technical data interpretation skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

  Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones   Direct reports 1-4 to start with. Location Gurgaon, Haryana (INDIA) Last date to submit the applications: 30.09.2023  

Job Title: Software Tester Job Description: We are seeking a skilled and motivated Software Tester with at least 1 year of experience to join our dynamic quality assurance team. As a Software Tester, you will play a crucial role in ensuring the quality and reliability of our software products through rigorous testing and validation processes. Your attention to detail, critical thinking abilities, and dedication to delivering high-quality software will contribute to our mission of providing exceptional user experiences. Key Responsibilities:  

• Collaborate with cross-functional teams, including developers, product managers, and designers, to understand project requirements and identify testable features.
• Create detailed, well-structured test plans, test cases, and test scripts based on project specifications and user stories.
• Execute manual and automated tests to validate the functionality, performance, security, and usability of software applications.
• Identify and document defects with clear and concise steps to reproduce, using issue tracking systems.
• Perform regression testing to ensure that previously identified issues have been resolved and that new changes do not introduce new defects.
• Participate in continuous improvement initiatives to enhance testing processes, tools, and methodologies.
• Communicate effectively with team members to report testing progress, results, and potential risks in a timely manner.
• Collaborate with developers to troubleshoot and reproduce reported issues, aiding in their resolution.
• Stay up-to-date with industry trends, best practices, and emerging technologies related to software testing.

Requirements:

• Bachelor's degree in Computer Science, Information Technology, or related field, or equivalent work experience.
• A minimum of 1 year of professional experience in software testing.
• Solid understanding of software development life cycles, testing methodologies, and quality assurance principles.
• Proficiency in creating and executing test plans, test cases, and test scripts.
• Experience with manual testing and exposure to automated testing tools is a plus.
• Familiarity with bug tracking systems and version control tools.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Ability to work collaboratively in a team environment and also independently with minimal supervision.

  Benefits:

• Competitive salary and benefits package.
• Opportunity to work in a fast-paced and pharma innovative environment.
• Professional growth and development opportunities.
• Exposure to cutting-edge technologies and projects.
• Collaborative and inclusive work culture.

  If you are passionate about quality assurance and have a proven track record of delivering reliable software, we encourage you to apply for this exciting opportunity. Join our team and contribute to the development of high-quality software solutions that meet and exceed user expectations.

Job purpose

To carry out Regulatory Review and Compilation of Technical documentation & dossiers as part of Life Cycle Management of products in compliance to applicable regulations and guidelines.

Education & Experience

• Master’s degree in Pharma discipline.
• 1-3  years of experience in handling Regulatory Affairs function.

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills.
• Strong project management skills.
• Excellent interpersonal skills including problem solving.
• Strong negotiation skills.
• Excellent oral and written communication skills with strong presentation skills.
• Significant knowledge of global, regional, national and other document development guidelines.
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills.
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills.
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner.
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines.

Other Requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

• • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents, for regulatory filings in emerging markets, for DDReg clients.
  • Assist in development of high quality dossier for various markets.
  • Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier compilation.
  • Closure of comments with the cross functional team & review of additional data generated in response to review comments per country.
  • Compilation of Dossier.
  • Review of registration dossier (m1-m5) as per country specific regulatory requirements.
  • Deficiencies response management from various authorities by coordinating stakeholders for getting documents and compilation and review of response and compile response to queries from the MOH.
  • Updation of the dossier as per the queries responded (inclusive of all countries).
  • Demonstrate subject matter and area expertise.
  • Collaborate with internal and external clients.
  • Supporting and enabling effective and efficient communication that results in operational excellence.
  • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites.

Location

• • Gurgaon, Sector-49