Alembic Pharmaceuticals Limited has announced a new Regulatory Affairs Executive (API) job opening in Vadodara, Gujarat. This opportunity is ideal for candidates with 1โ3 years of Regulatory Affairs experience and strong knowledge of DMF compilation, ICH guidelines, and regulatory documentation.
Professionals with B.Pharm, M.Pharm, or M.Sc qualifications looking to grow in API regulatory affairs jobs in India should consider applying for this role. The position focuses on DMF submissions for US and Brazil markets, regulatory documentation review, and coordination across departments for regulatory filings.
Key Responsibilities
The Regulatory Affairs Executive (API) will handle several critical regulatory tasks including:
- DMF compilation for US and Brazil markets
- Coordinating with internal departments to collect documents required for regulatory filing
- Reviewing regulatory documents for submission adequacy and compliance
- Supporting regulatory documentation required for business development activities
- Ensuring regulatory submissions align with ICH guidelines and global regulatory standards
- Assisting in preparation and review of API regulatory dossiers
Required Qualifications
Candidates applying for the Alembic Pharma Regulatory Affairs Executive job should meet the following criteria:
Education
- B.Pharm (Bachelor of Pharmacy)
- M.Pharm (Any specialization)
- M.Sc (Science โ relevant specialization)
Experience
- 1โ3 years experience in Regulatory Affairs
- Exposure to API regulatory submissions and DMF documentation
Skills
- Knowledge of ICH guidelines
- Understanding of USDMF regulatory processes
- Regulatory documentation and compliance expertise
- Cross-functional coordination skills
- Regulatory dossier preparation knowledge
Preferred Candidate Profile
The ideal candidate for this API Regulatory Affairs job in Vadodara will have:
- Experience working in pharmaceutical API regulatory affairs
- Familiarity with US and Brazil regulatory filing requirements
- Ability to review technical documentation for regulatory adequacy
- Strong communication and documentation management skills
Salary and Benefits
While the company has not disclosed the salary publicly, the estimated compensation for this role based on industry standards is:
Estimated Salary: โน4,00,000 โ โน7,00,000 per year (INR)
Additional benefits may include:
- Performance-based growth opportunities
- Exposure to international regulatory markets
- Professional development in global regulatory compliance
- Experience working with a reputed pharmaceutical organization
Job Location
Vadodara, Gujarat, India
Alembic Pharmaceuticals is one of India’s leading pharmaceutical companies with a strong presence in API manufacturing and global regulatory markets.
How to Apply
Interested candidates who meet the eligibility criteria can send their updated resume to:
Email: creyesha.macwan@alembic.co.in
Applicants should include relevant Regulatory Affairs experience, DMF compilation work, and ICH guideline knowledge in their CV.