Alembic Pharmaceuticals Hiring Executive – Regulatory Affairs (API)

Alembic Pharma Hiring Regulatory Affairs Executive – API – Vadodara

Apply for Regulatory Affairs Executive API role at Alembic Pharma, Vadodara. B.Pharm/M.Pharm graduates with 3–6 years of experience required.

Alembic Pharmaceuticals, a pioneer in the Indian pharmaceutical industry, is inviting applications for the position of Executive – Regulatory Affairs (API) at its corporate office in Vadodara, Gujarat. This role offers an exciting opportunity to contribute to global drug regulatory compliance in one of India’s most respected pharma companies.

Company Overview

Alembic Pharmaceuticals Limited, with over a century of excellence, is one of India’s most reputed pharma companies known for innovation, trust, and global presence. The company is involved in the research, development, manufacturing, and marketing of generics, branded formulations, and active pharmaceutical ingredients (APIs). With approvals from regulatory agencies such as USFDA, EMA, MHRA, and more, Alembic is synonymous with quality and reliability worldwide.

Job Role & Responsibilities

As an Executive in Regulatory Affairs (API), the selected candidate will be responsible for:

• Compiling and reviewing Drug Master Files (DMFs) and Certificates of Suitability (CEPs).
• Preparing and submitting regulatory documents for APIs.
• Addressing deficiencies raised by regulatory authorities and customers.
• Reviewing compendial monographs to ensure compliance with changing regulatory requirements.
• Reviewing analytical method validations, KSMs, intermediates, and API specifications.
• Managing customer communications and responding to regulatory queries effectively.
• Issuing Letters of Access (LOA), regulatory authorizations, and declarations.
• Preparing and submitting prior and post-approval change notifications.
• Tracking and monitoring global regulatory filings, procedural changes, and updates.

Eligibility / Qualifications

• Educational Background: B. Pharmacy, M. Pharmacy (Pharmaceutics, Pharmaceutical Chemistry, Quality Assurance, Pharmaceutical Analysis).
• Experience: 3 to 6 years of hands-on experience in API regulatory affairs.
• Skills Required:
  • In-depth knowledge of DMF/CEP preparation and submission.
  • Familiarity with ICH, USFDA, EMA, and global regulatory requirements.
  • Strong communication and documentation skills.
  • Ability to handle customer and regulatory authority communications.

Location & Salary

• Location: Corporate Office, Vadodara, Gujarat.
• Salary: Competitive, as per industry standards and candidate experience.

Application Process

Interested candidates who meet the above criteria can share their updated resumes with the HR team at:

creyesha.macwan@alembic.co.in

Why Join Alembic Pharma?

• Be part of a legacy pharma organization with 100+ years of trust.
• Exposure to global regulatory frameworks and international markets.
• Work with experienced professionals in the API regulatory domain.
• Attractive salary, learning opportunities, and career growth prospects.

FAQs

1. Who can apply for Alembic Pharma’s Regulatory Affairs Executive role?
Candidates with B.Pharm or M.Pharm degrees and 3–6 years of API regulatory affairs experience are eligible.

2. Where is the job located?
The role is based at Alembic Pharma’s corporate office in Vadodara, Gujarat.

3. What skills are required for this role?
Candidates should have expertise in DMF/CEP compilation, global regulatory requirements, and strong communication skills.

4. How do I apply?
Send your CV to creyesha.macwan@alembic.co.in.

5. Is this role open for freshers?
No, the role requires 3–6 years of relevant experience.

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