Assistant Manager, Regulatory Affairs
Amneal Pharmaceuticals
Date: 2 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Key Responsibilities
JOB DESCRIPTION
Required Qualifications & Experience
JOB DESCRIPTION
- Dossier Preparation & Submissions
- Prepare, review, and submit CTD / ACTD / country‑specific dossiers for:
- New product registrations
- Line extensions (strength, pack size, shelf life)
- Variations and renewals
- Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, Pharmacovigilance, and Manufacturing teams.
- Ensure dossier compliance with WHO, ICH, and local authority guidelines.
- Regulatory Strategy & Market Support
- Develop registration strategies for RoW markets considering country‑specific regulations.
- Support business development by providing regulatory feasibility and timelines for new markets/products.
- Assess regulatory impact for formulation/site changes.
- Regulatory Lifecycle Management
- Manage post‑approval changes, including:
- CMC variations
- Labeling updates
- Artwork changes
- Track and ensure timely renewals/re‑registrations.
- Maintain approved product documentation and regulatory databases.
- Health Authority Interaction
- Handle deficiency letters / queries from regulatory agencies.
- Prepare responses in coordination with internal stakeholders.
- Liaise with local agents, consultants, and partners for RoW countries.
- Compliance & Intelligence
- Monitor regulatory guideline updates for RoW markets.
- Ensure submissions comply with the latest country requirements.
- Support internal audits, regulatory inspections, and due‑diligence audits.
- Team & Project Coordination
- Mentor junior team members and review their regulatory work.
- Track regulatory milestones and ensure alignment with project timelines.
- Participate in cross‑functional meetings for project planning and risk assessment.
- LATAM: Brazil, Mexico, Colombia, Peru, Chile, Guatemala
- MENA/GCC region
- CIS: Russia, Ukraine, Kazakhstan,etc.
- ASEAN: Philippines, Vietnam, Thailand, Malaysia
Required Qualifications & Experience
- Educational Background:
- M.Pharm / B.Pharm
- Experience:
- 8–10 years in Pharmaceutical Regulatory Affairs
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Executive, Product Development - R&D (Microsphere Injectable Specific F&D Injectable)
Amneal Pharmaceuticals,
Ahmedabad, Gujarat
6 days ago
Key Responsibilities JOB DESCRIPTION Strong understanding of formulation and development of sterile injectable dosage forms. Hands-on experience or exposure to complex injectable systems (microspheres, liposomes, polymer-based formulations preferred). Familiarity with pharmaceutical development documentation and regulatory expectations. Basic to intermediate knowledge of QbD concepts and application in product development. Good cross-functional coordination and communication skills. Ability to work in a regulated...
Calibration Laboratory Head
Zigsaw,
Ahmedabad, Gujarat
2 weeks ago
Calibration Laboratory HeadExperience: 4-6 YearsLocation: Ahmedabad, Work from OfficeSalary: 8-10 LPAAbout the Role:We are hiring a Calibration Laboratory Head to lead the technical direction and quality oversight of our calibration laboratory for gas, dust, and meteorological instruments. This role involves defining calibration processes, developing SOPs, planning setups for new parameters and capabilities, and driving measurement accuracy improvement through structured testing.Key...
Junior Accountant
IMA India,
Ahmedabad, Gujarat
3 weeks ago
4 days leftEmployer Mantras2SuccessLocation AhmedabadPosted Jul 10, 2026Closes Jul 14, 2026Ref 5730762289Role Accountant / Management AccountantLevel Staff, Entry levelCertification OtherWork Mode Work from officeHours Full TimeOrganization Type Corporate You need to sign in or create an account to save Apply(This will open in a new window from which you will be automatically redirected to an external site after 5 seconds)...
