Assistant Manager or Deputy Manager

Role & responsibilities

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

Ensure all regulatory activities are conducted in compliance with relevant regulations, guidelines, and SOPs.

Review and analyze data to ensure accuracy and completeness of regulatory submissions.

Participate in regulatory audits and inspections as necessary.

Cross-Functional Collaboration:

Collaborate closely with R&D, Quality Assurance, and Clinical teams to gather necessary data for regulatory submissions.

Provide regulatory guidance to product development teams during the planning phase to ensure alignment with regulatory strategies.

Regulatory Intelligence:

Stay updated on emerging trends, changes, and advancements in regulatory affairs within the pharmaceutical industry.

Proactively communicate updates and potential impacts to internal stakeholders.