Job Archives
Profile: Associate – Regulatory Affairs - API
Location: Gurgaon, Haryana, India (Onsite)
Role Overview:
This role is a mid-level Regulatory Affairs (CMC) position focused on Module 3 (API) documentation for global markets including EU, UK, and US. The primary responsibility is to ensure that all Chemistry, Manufacturing, and Controls (CMC) data submitted to regulatory authorities is accurate, compliant, and aligned with global guidelines.
Job Descriptions:
- CMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -API
- Prepare and compile Section 322, QOS & QbR 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.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience:
- Master’s degree or bachelor's degree in Pharma - MSc Chemistry.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 to 6 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
- Excellent written and verbal communication skills with a strong attention to detail.
- Proficiency in regulatory submission software and MS Office applications.
- Good problem-solving and coordination skills
- Ability to work in a fast-paced, deadline-driven environment
Behavioural Competencies:
- Detail-oriented with high focus on quality and compliance
- Strong team player with collaborative mindset
- Ability to handle pressure and manage multiple submissions simultaneously.
Why to Join us:
- Growth Opportunities
- Learning Exposure
- Better Compensation
Job Features
Profile: Associate – Regulatory Affairs – API Location: Gurgaon, Haryana, India (Onsite) Role Overview: This role is a mid-level Regulatory Affairs (CMC) position focused on Module 3 (API) d...
Profile: Associate – Regulatory Affairs (M1)
Location: Gurgaon, Haryana, India (Onsite)
Role Overview:
We are hiring a detail-driven Associate – Regulatory Affairs (Module 1) to support global submission activities and ensure compliance with evolving regulatory requirements. The role involves compiling, reviewing, and managing Module 1 dossiers while coordinating with cross-functional teams to meet critical submission timelines. The ideal candidate brings strong knowledge of regional regulatory frameworks, high attention to detail, and the ability to manage documentation with precision
Job Descriptions:
- Prepare, review, and compile Module 1 of regulatory submissions in accordance with regional requirements.
- Maintain up-to-date knowledge of global regulatory guidelines and ensure company compliance.
- Coordinate with cross-functional teams including clinical, quality, and manufacturing to gather necessary documentation.
- Assist in the preparation and maintenance of regulatory dossiers and submission tracking.
- Support interaction with health authorities and respond to regulatory queries promptly and accurately.
- Contribute to the development and implementation of regulatory strategies to facilitate product approvals.
- Ensure documentation accuracy, completeness, and adherence to company and regulatory standards.
Education & Experience:
- Bachelor’s / master’s degree in pharmacy / Life Sciences
- Regulatory Affairs certification (optional but preferred)
Knowledge, Skills and Abilities:
- Excellent written and verbal communication skills with a strong attention to detail.
- Proficiency in regulatory submission software and MS Office applications.
- Good problem-solving and coordination skills
- Ability to work in a fast-paced, deadline-driven environment
Behavioural Competencies:
- Detail-oriented with high focus on quality and compliance
- Strong team player with collaborative mindset
- Ability to handle pressure and manage multiple submissions simultaneously.
Why to Join us:
- Growth Opportunities
- Learning Exposure
- Better Compensation
Job Features
Profile: Associate – Regulatory Affairs (M1) Location: Gurgaon, Haryana, India (Onsite) Role Overview: We are hiring a detail-driven Associate – Regulatory Affairs (Module 1) to support globa...
Job Descriptions
- CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
- Development and implementation of regulatory strategies, processes and timelines for grant of ANDAs.
- 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 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.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience
- Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Excellent interpersonal skills including problem solving
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of US Regulations
- Excellent computer skills; 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.
- 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
Location
Gurgaon, Haryana (INDIA)
Job Features
Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regula...
Manager _US_ (Onsite)- Gurugram
Job Purpose:
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for US Markets.
Key Responsibilities:
- Regulatory Compliance:
Strong understanding of U.S. regulatory requirements, particularly FDA guidelines, and will be responsible for preparing and submitting regulatory documentation for ANDA, maintaining compliance records, and liaising with regulatory agencies. Knowledge about post approval activities is an added advantage. - eCTD/CTD Sequence Review:
Maintain up-to-date knowledge of eCTD requirements and review of the sequence to ensure submission quality and compliance with regulatory standards. - Query Handling & Documentation:
Draft and review regulatory authority responses. Ensure clarity, regulatory alignment, and timely submission. - Functional File Preparation:
Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting. Ensure technical accuracy and reduce rework. - Artwork & Labeling Review:
Prepare and review artworks and comparative labeling texts. Ensure accuracy, consistency, and regulatory compliance. - Project Tracking & Documentation:
Maintain trackers, task planners, product history logs, and query records. Participate in client meetings and contribute to regulatory planning and decision-making. - Team Collaboration & Communication:
Collaborate with internal stakeholders and external clients. Ensure timely follow-ups, documentation clarity, and professional engagement.
Educational Qualifications:
B Pharm/ M Pharm
Soft Skills:
- Strong communication and interpersonal skills
- Time management and multitasking
- Analytical thinking and collaboration
- Positive, adaptable attitude
Job Features
Job Purpose: We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candi...
Job Title: Assistant Manager – Regulatory Affairs (EU & UK)
Location: Gurgaon, Haryana (India)
Experience: 4–6 Years
Qualification: Master’s Degree in Pharmacy (M.Pharm or equivalent)
Role Overview
We are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines.
Key Responsibilities
Conduct comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets.
Perform Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards.
Develop and implement regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications.
Prepare and compile new CTD dossiers, variations, and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards.
Critically review documentation to ensure internal consistency, compliance with regulatory expectations, and support regulatory excellence.
Collaborate with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions.
Ensure effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines.
Maintain high-level knowledge of current country-specific regulations, keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA).
Education & Experience
Master’s degree in Pharmacy or equivalent qualification.
4 to 6 years of relevant experience in Regulatory Affairs, with a focus on EU and/or UK submissions.
Equivalent combinations of education, training, and practical experience may also be considered.
Key Skills & Competencies
Strong technical skills in data analysis and interpretation of regulatory documentation.
Excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach.
Effective negotiation and communication skills for liaising with internal teams and external agencies.
Proficient in drafting and reviewing documents in line with global, regional, and national regulatory standards.
Expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word.
Strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly.
Demonstrated ability to analyze data systematically, apply regulatory logic, and compile well-organized submissions.
Collaborative, results-driven, and self-motivated with the flexibility to adapt to shifting priorities.
Capable of delivering high-quality outputs under pressure and within aggressive timelines.
Other Requirements
Flexibility to work in cross-time-zone schedules, as needed to support global project coordination or agency interactions.
Why Join Us?
Be part of a high-performing regulatory team that plays a critical role in bringing impactful pharmaceutical products to patients globally. Work in a collaborative, fast-paced environment where your expertise shapes international market access strategies.
Job Features
Job Title: Assistant Manager – Regulatory Affairs (EU & UK) Location: Gurgaon, Haryana (India) Experience: 4–6 Years Qualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Rol...
Job Descriptions
- CMC review of technical documentation for regulatory filings to various markets.
- Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN.
- Review of CTD dossiers , variations, change controls, renewals and 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.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience
- Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Excellent interpersonal skills including problem solving
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of US Regulations
- Excellent computer skills; 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.
- 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
Location
Gurgaon, Haryana (INDIA)
Job Features
Job Descriptions CMC review of technical documentation for regulatory filings to various markets. Development and implementation of regulatory strategies, processes and timelines for grant of MA- Afri...
Manager _ Medical Writing_ Regulatory Affairs
Job Purpose:
DDReg Pharma Pvt Ltd is seeking an experienced Regulatory Affairs Medical Writer responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. The role involves preparation of complex CTD modules, quality control of submissions, gap analysis, and support in responding to regulatory queries. The ideal candidate will collaborate cross-functionally and support team development and process improvement.
Key Responsibilities:
- Authoring & Review of Regulatory Documents
•Draft high-quality medical and regulatory documents in accordance with global guidelines.
•Prepare complex regulatory documents such as:
-- Module 2 components (Quality Overall Summary / Nonclinical Overview / Clinical Overview)
--Regulatory strategy reports
•Ensure consistency, scientific accuracy, and regulatory compliance across documents. - Quality Control (QC) of Documents
•Perform QC review of simple and complex documents including:
--SPC, PI, PIL, RMP
--Compiled modules for small molecules and biosimilars
--SPL, BE templates, TIF
--Aggregate reports, Expert reports
•Ensure documents are delivered with high quality and within agreed timelines. - Gap Analysis
•Perform gap assessment for small molecules and biosimilar products.
•Evaluate non-clinical and clinical data provided by clients to identify deficiencies affecting product submission/approval.
•Draft structured gap reports/sheets and propose corrective actions. - Query Response & Literature Support
•Support regulatory query responses by evaluating existing documents and addressing authority/client questions.
•Conduct literature searches to update documentation and prepare query response reports as required.
•Work with cross-functional teams to ensure clarity and customer satisfaction. - Mentoring & Training
•Support resolution of technical/medical doubts raised by team members.
•Provide on-the-job training and guidance to direct reportees.
•Identify training needs for self and team on a quarterly basis.
Key Skills & Requirements:
- Bachelor’s/Master’s/PhD in Life Sciences, Pharmacy, Biotechnology, or related field.
- 7–10 years of experience in regulatory/medical writing.
- Strong understanding of CTD format and global regulatory guidelines (ICH, FDA, EMA, CDSCO).
- Hands-on experience in:
--Module 2 documents
--Data analysis for gap assessment
--QC of regulatory deliverables - Excellent written communication, analytical skills, and attention to detail.
- Proficiency in MS Office and documentation systems.
Why Join Us
- Opportunity to contribute to key regulatory submissions
- Exposure to global health authority expectations
- Skill development and continuous learning environment
- Collaborative work culture
Job Features
Job Purpose: DDReg Pharma Pvt Ltd is seeking an experienced Regulatory Affairs Medical Writer responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in a...
Job Descriptions
- CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
- Development and implementation of regulatory strategies, processes and timelines for grant of ANDAs.
- 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 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.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience
- Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Excellent interpersonal skills including problem solving
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of US Regulations
- Excellent computer skills; 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.
- 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
Location
Gurgaon, Haryana (INDIA)
Job Features
Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regula...