Assistant Manager

Job Title: Assistant Manager – Regulatory Affairs Operations (Biopharma – Asia Region)

Department: Regulatory Affairs

Reports To: General Manager – Regulatory Affairs

Job Summary:

We are seeking a motivated and detail-oriented Assistant Manager – Regulatory Affairs Operations to manage and support regulatory submissions, product lifecycle activities, and compliance for biopharmaceutical products across the Asia region. The ideal candidate will have a sound understanding of regional regulatory requirements, experience with dossier preparation and post-approval activities, and strong technical expertise in biologics, biosimilars, and analytical methods.

Key Responsibilities:

Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions.

Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines.

Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions.

Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines.

Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation.

Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions.

Prepare regulatory documents for GMP inspections, tender submissions, and related regulatory filings.

Stay updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations.

Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements.

Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines.

Support the development of regulatory strategies for new product launches and geographic expansion within Asia.

Ensure compliance with global and local regulatory SOPs and documentation standards.

Requirements:

Postgraduate degree in Life Sciences, Biotechnology, Pharmacy, or a related field.

Minimum 6-8 years of regulatory affairs experience, with a strong focus on biopharmaceutical products in the Asia region.

Deep knowledge of country-specific regulatory frameworks .

Proficient in CTD and ACTD dossier formats.

Understanding of ICH guidelines and biosimilar regulatory pathways.

Strong technical knowledge in analytical methods, bioprocesses, and quality documentation for biologics.

Experience with GMP audit documentation, regulatory inspections, and health authority interactions.

Excellent organizational, communication, and project management skills.

Interested candidates can send CV to prathap.s@hetero.com