Career Openings
Job Descriptions
- Support the drafting of basic medical and regulatory documents such as Prescribing Information (PI), biowaiver justifications, clinical and non-clinical overviews, Structured Product Labeling (SPL), bioequivalence (BE) templates, Technical Information Files (TIF), and supporting regulatory documents under senior guidance.
- Assist in reviewing source documents, clinical and non-clinical study reports, and published scientific literature to extract relevant information for regulatory submissions.
- Perform preliminary quality checks on regulatory and medical writing documents to ensure accuracy, formatting consistency, and alignment with regulatory guidelines.
- Support gap analysis activities for small molecules and biosimilars by identifying missing or unclear information in clinical and non-clinical datasets.
- Assist in preparing draft responses to regulatory or client queries, including updating documents based on feedback and review comments.
- Participate in literature searches and reference management to support medical and regulatory documentation.
- Learn and apply global regulatory guidelines and document standards relevant to medical writing.
- Support project tracking activities by maintaining documentation, version control, and work trackers.
- Communicate progress and challenges effectively with team members and supervisors.
- Demonstrate a proactive learning attitude, attention to detail, and willingness to adapt to evolving regulatory requirements.
Education
- Master’s degree in pharmacology (M.Pharm - Pharmacology) Only.
Knowledge, Skills and Abilities
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Excellent written and spoken English
- Result-oriented and deadline-driven approach
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 Support the drafting of basic medical and regulatory documents such as Prescribing Information (PI), biowaiver justifications, clinical and non-clinical overviews, Structured Product ...
Position: Sr. Associate – Regulatory Affairs _Food
Role Summary:
The Sr. Associate – Regulatory Affairs at DDReg Pharma Pvt Ltd will support regulatory strategy, submissions, and compliance for health supplements and nutraceuticals in India. The role demands strong hands-on expertise in FSSAI regulations, filings, and regulator interactions, along with the ability to manage end-to-end regulatory processes for clients.
Job Descriptions
- Manage preparation, compilation, review, and submission of dossiers for FSSAI product approvals, licenses, and registrations.
- Handle FoSCoS portal activities including new applications, renewals, and modifications.
- Respond to regulatory queries, deficiencies, and notices from FSSAI authorities.
- Ensure compliance with FSSAI regulations including Nutraceuticals Regulations and Labelling & Packaging requirements.
- Provide regulatory guidance to internal teams and clients on product classification, claims, and ingredient compliance.
- Build and maintain strong liaison with FSSAI officials and industry stakeholders.
- Support regulatory strategy and intelligence activities for nutraceutical products.
- Maintain documentation and support audits and inspections.
Knowledge, Skills and Abilities
- Strong knowledge of FSSAI regulations and compliance systems.
- Hands-on experience with FoSCoS filings and documentation.
- Proven ability to interface with regulatory authorities and manage filings independently.
- Excellent communication, attention to detail, and stakeholder management skills.
Qualification and Experience
- Bachelor’s or Master’s degree in Food Technology, Pharmacy, Life Sciences, Nutrition or related field.
- 3–6 years' experience in regulatory affairs within nutraceuticals/health supplements/food/pharma sector.
- Mandatory experience in FSSAI filings and regulatory processes.
Location
Gurgaon, Haryana (INDIA)
Job Features
Position: Sr. Associate – Regulatory Affairs _Food Role Summary: The Sr. Associate – Regulatory Affairs at DDReg Pharma Pvt Ltd will support regulatory strategy, submissions, and compliance fo...
Position: Sr. Associate – Regulatory Affairs (Biologicals & Vaccines)
Role Summary:
The Sr. Associate – Regulatory Affairs (Biologicals & Vaccines) at DDReg Pharma Pvt Ltd will be responsible for managing regulatory submissions, approvals, and compliance for biological/biosimilar products and vaccines in India. The role requires strong expertise in CDSCO regulations, end-to-end dossier handling, and proactive engagement with regulatory authorities.
Job Descriptions
- Prepare, compile, and submit regulatory dossiers (CTD/eCTD) for biologicals and vaccines to CDSCO.
- Manage applications for clinical trials, import licenses, test licenses, and marketing authorizations.
- Handle filings via SUGAM portal including new submissions, variations, amendments, and renewals.
- Respond to CDSCO queries, deficiencies, and regulatory communications professionally and on time.
- Ensure compliance with applicable guidelines including New Drugs & Clinical Trial Rules (NDCTR) and biologics guidelines.
- Coordinate with internal and client teams for documentation, data requirements, and regulatory strategy.
- Maintain up-to-date knowledge of regulatory changes, circulars, and notifications from CDSCO.
- Support audit readiness and inspection activities.
Knowledge, Skills and Abilities
- Strong knowledge of CDSCO regulations, NDCTR, and biologics regulatory pathways.
- Proficiency in dossier preparation (CTD/eCTD) and SUGAM portal submissions.
- Demonstrated ability to handle regulatory filings independently.
- Strong networking and liaisoning skills with CDSCO authorities.
- Excellent analytical, documentation, and communication skills.
- Ability to work in a fast-paced consulting environment with multiple projects.
- Act as key liaison with CDSCO officials, subject experts, and regulatory consultants.
- Establish and maintain effective professional relationships with regulatory authorities.
- Represent DDReg Pharma in regulatory meetings and discussions with CDSCO.
- Coordinate with industry forums and stakeholders when required.
Qualification and Experience
- Bachelor’s or master’s degree in pharmacy, Life Sciences, Biotechnology, or related field.
- 3–6 years of regulatory affairs experience in biologicals, vaccines, or pharma industry.
- Hands-on experience with CDSCO submissions and regulatory pathways is mandatory.
Location
Gurgaon, Haryana (INDIA)
Job Features
Position: Sr. Associate – Regulatory Affairs (Biologicals & Vaccines) Role Summary: The Sr. Associate – Regulatory Affairs (Biologicals & Vaccines) at DDReg Pharma Pvt Ltd will be resp...
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...
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...