Regulatory Manager

Qualifications:

✔ Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related fields.

✔ 3–5 years of experience in regulatory affairs, or contract manufacturing tie-ups within the pharmaceutical industry.

✔ Strong understanding of the Indian pharma market and licensing processes.

✔ Excellent negotiation, communication, and relationship management skills.

✔ Entrepreneurial mindset with the ability to thrive in a fast-paced environment.

Key Responsibilities:

- Prepare, review, and submit regulatory dossiers (CTD/eCTD/ACTD) for product registration, variations, and renewals to the Food and Drug Administration (FDA/ other global authorities).

- Ensure dossiers contain accurate CMC, non-clinical, and clinical data as required by each market.

- Review, prepare Non-Clinical and Clinical Data, Risk Management Plan (RMP), Periodic Safety Update Report (PSUR)

- Ensure compliance with national and international regulatory requirements, guidelines, and timelines.

- Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Marketing) to gather and verify technical documents needed for submissions.

- Coordinate with API vendors for DMFs, technical queries, and COAs.

- Coordinate with the BE/CDP centers

 - Support manufacturing sites during audits, inspections, and GMP compliance activities.

- Ensure compliance with local and international GMP regulatory requirements

- Provide regulatory support for product launches.

- Monitor changes in regulatory guidelines and communicate updates to management and relevant departments.

- Keep proper records of submissions, approvals, and correspondence with health authorities.

- Assist in developing regulatory strategies for new products or markets.

- Support pharmacovigilance and post-marketing surveillance requirements as needed.

Skills and Knowledge: 

- Strong understanding of global regulatory requirements (USFDA, EMA, MHRA, TGA, Health Canada, CDSCO – India, ASEAN, WHO).

- Experience in preparation, review, and submission of regulatory dossiers (DMF, ANDA, NDA, MAA, CTD/eCTD).

- Knowledge of variations, renewals, post-approval changes.

- Familiarity with ICH, GxP, and pharmacovigilance regulations.

- Good communication and scientific writing skills.

- Proficiency in MS Office, regulatory submission tools/software.

Other Requirements:

* Attention to detail and accuracy in documentation.

* Strong organizational and project management skills.

* Ability to coordinate with R&D, QA, QC, and manufacturing teams.

* Stay updated with global regulatory changes (ASEAN, CIS, EAEU, USFDA, EU, GCC, WHO, etc.).

* Prepare regulatory strategies for new product development.

* Communicate with clients, partners, and manufacturers regarding regulatory requirements.

Please send your resume to : hr2@getmeds.ph; hr@getmeds.ph; dra2@2mginc.com