Assistant Manager - Regulatory Affairs

Role & responsibilities

• Should have In-depth knowledge of the US ANDA (Abbreviated New Drug Application) requirements, with expertise in the entire process from submission to approval. This includes familiarity with the regulatory framework for generic drug approval by the FDA, the preparation and review of bioequivalence studies, drug master file (DMF) submissions, labeling requirements, and the integration of Good Manufacturing Practices (GMP) into product development.

• Proficient in managing US post-approval changes, including: Prior approval supplements (PAS): Expertise in preparing and submitting PAS for significant changes that require FDA approval before implementation.

• Changes Being Effected in 30 days (CBE-30): Knowledge of regulatory requirements for submitting changes to approved drugs that can be implemented within 30 days after FDA submission.
• Changes Being Effected (CBE-0): Proficiency in managing changes to approved drugs that can be implemented immediately after submission to the FDA, with appropriate documentation to support these changes.

• Annual Reports: Expertise in preparing and submitting annual reports to the FDA, ensuring timely updates regarding product manufacturing, labeling, and stability data, and compliance with regulatory expectations.

• Extensive experience in eCTD (electronic Common Technical Document) publishing, including the preparation, submission, and management of eCTD submissions to regulatory authorities. This also includes handling SPL (Structured Product Labeling) publishing for product labeling requirements and ensuring compliance with FDA and other regulatory bodies' guidelines for electronic submissions.

Preferred candidate profile

• Candidate should have Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.
• 10+ years of progressive experience in Regulatory Affairs within the pharmaceutical industry, with a focus on US generic drugs.
• Demonstrated in-depth knowledge of US ANDA requirements and the generic drug approval process.
• Proven expertise in managing US post-approval changes (PAS, CBE-30, CBE-0, Annual Reports).
• Extensive experience with eCTD publishing and SPL publishing.
• Strong understanding of FDA regulations and guidelines, including GMP.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• Strong attention to detail and organizational skills.