Senior Manager

Biocon Biologics Limited; Bengaluru; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Biocon Biologics Limited is seeking a Senior Manager Global Regulatory Affairs to drive regulatory strategy and submissions for peptide and complex generic products across the US, EU, UK, and Emerging Markets. You will lead cross-functional teams, manage lifecycle activities, and interact with health authorities to ensure compliant, timely approvals.

The role requires extensive experience with CTD/eCTD dossiers, ANDA programs, and post-approval changes, with a strong emphasis on CMC alignment

Qualifications

• M.Pharm / M.Sc. / Pharm.D. / Ph.D. or equivalent qualification in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline.
• 12–15 years of experience in pharmaceutical Regulatory Affairs with global exposure.
• Hands-on with submissions and lifecycle management for US, EU, UK, and Emerging Markets.
• Experience with peptide products, complex generics, injectable products, or technically complex drug products preferred.
• Strong knowledge of CMC regulatory requirements, CTD/eCTD, ANDA, and post-approval changes.

Responsibilities

• Develop and execute regulatory strategies for peptide and complex generic products across US, EU, UK, and Emerging Markets.
• Lead review and submission of regulatory dossiers in CTD, eCTD, ACTD, and country formats.
• Drive regulatory planning from development through submission, approval, launch readiness, and post-approval lifecycle management.
• Identify regulatory gaps and risks early; provide mitigation with cross-functional teams.
• Coordinate and respond to health authority queries with timely, accurate submissions.
• Support FDA Pre-ANDA meetings, Scientific Advice, and other health authority interactions.
• Lead regulatory activities for renewals, variations, and post-approval changes across markets.
• Maintain regulatory records in RIMS and ensure traceability of submissions and approvals.

Skills

Global regulatory strategy

Regulatory submissions

Cross-functional leadership

Regulatory lifecycle management

Regulatory affairs

Education

M.Pharm / M.Sc. / Pharm.D. / Ph.D.

Tools

RIMS

CTD/eCTD dossiers

Job description

Job Description

Senior Manager Global Regulatory Affairs to lead regulatory activities for peptide and complex generic products across the United States, European Union, United Kingdom, and Emerging Markets. The role will be responsible for developing and executing global regulatory strategies, leading dossier submissions and health authority responses, supporting scientific advice and pre-submission interactions, and managing the regulatory lifecycle of products across multiple markets. The ideal candidate will bring strong experience in CTD/eCTD submissions, ANDAs, EU/UK regulatory procedures, global registrations, regulatory strategy, CMC documentation, health authority interactions, and post-approval lifecycle management. Experience with peptide products, complex injectables, or other complex generic products is highly desirable.

Key Roles & Responsibilities

1. Global Regulatory Strategy & Submissions

• Develop and execute regulatory strategies for peptide and complex generic products across the US, EU, UK, and Emerging Markets.
• Lead review and submission of regulatory dossiers in CTD, eCTD, ACTD, and country-specific formats, as applicable.
• Drive regulatory planning from development through submission, approval, launch readiness, and post-approval lifecycle management.
• Assess country-specific regulatory requirements, submission pathways, documentation gaps, and potential regulatory risks.
• Ensure high-quality and timely submissions in accordance with applicable health authority requirements and committed project timelines

2. Cross-Functional Regulatory Leadership

• Coordinate closely with R&D/Formulation Development, Analytical Development, QA, QC, Manufacturing, Clinical/BE, Supply Chain, Program Management, Commercial, and other stakeholders to obtain regulatory submission documentation.
• Review documents received from cross-functional teams for adequacy, completeness, scientific consistency, and regulatory compliance before incorporation into regulatory dossiers.
• Provide regulatory guidance to development and CMC teams to ensure that development programs and supporting documentation are aligned with target market requirements.
• Identify potential regulatory gaps and risks early and facilitate appropriate mitigation plans with relevant stakeholders.

3. Health Authority Queries & Regulatory Interactions

• Develop strategies for effective and timely responses to health authority deficiencies, information requests, and regulatory queries.
• Review and approve responses prepared by cross-functional teams to ensure scientific accuracy, consistency with the submitted dossier, and regulatory compliance.
• Coordinate multidisciplinary response teams and facilitate closure of agency queries within regulatory timelines.
• Support review, and coordination of FDA Pre-ANDA meetings, Scientific Advice meetings, and other health authority interactions, as applicable.

4. Product Lifecycle Management

• Lead regulatory activities associated with renewals, variations, supplements, amendments, annual reporting, and other post-approval changes across global markets.
• Review and approve change controls and assess regulatory impact across affected markets.
• Determine appropriate implementation and submission strategies for post approval changes in collaboration with relevant stakeholders.
• Review regulatory approval packages and communicate approval conditions, commitments, and implementation requirements to cross-functional teams.

5. US Regulatory Activities

• Provide regulatory oversight for ANDA submissions and post-approval regulatory activities for the US market.
• Coordinate regulatory fee-related activities, including GDUFA cover sheets for ANDA-related fees, facility fees, and program fees, where applicable.
• Support coordination of regulatory agency, consultant, and partner-related payments.
• Contribute to regulatory strategy and documentation for Pre-ANDA interactions and other FDA engagements.

6. EU & UK Regulatory Activities

• Support and manage applicable EU and UK submission procedures, including national and multi-country regulatory activities.
• Coordinate national-phase submission activities following European procedures, including collaboration with local regulatory consultants and translation vendors.
• Oversee documentation required for renewals, variations, post-approval commitments, and lifecycle management activities.
• Facilitate implementation of approvals across relevant EU/UK markets.

7. Emerging-Market Registrations

• Lead dossier preparation and country-specific submission activities for Emerging Markets in accordance with applicable CTD, ACTD, or national requirements.
• Coordinate country-specific documentation, samples, legalization, translations, certificates, and other registration requirements, as applicable.
• Ensure timely submission of registration samples required by health authorities.
• Coordinate with local regulatory representatives, partners, consultants, and internal stakeholders to support submission and approval activities.

8. Regulatory Compliance & Systems

• Ensure timely and accurate updates to Regulatory Information Management Systems (RIMS), including submission records, deficiency tracking, approval information, document archives, and dossier trackers.
• Maintain appropriate regulatory records and ensure traceability of submissions, correspondence, commitments, and approvals.
• Review documentation supporting GMP applications and manufacturing/site related regulatory submissions, as applicable.
• Ensure regulatory commitments and agency requirements are appropriately tracked through closure.

Qualification & Experience

• M.Pharm / M.Sc. / Pharm.D. / Ph.D. or equivalent qualification in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related discipline.
• Approximately 12-15 years of experience in pharmaceutical Regulatory Affairs, preferably encompassing global markets.
• Strong hands-on experience with submissions and lifecycle management for the US, EU, UK, and Emerging Markets.
• Experience with peptide products, complex generics, injectable products, or technically complex drug products is strongly preferred.
• Good understanding of CMC regulatory requirements, CTD/eCTD dossier structure, ANDA requirements, EU/UK regulatory procedures, and post-approval change management.
• Experience in managing regulatory authority queries and multidisciplinary response teams.
• Experience with FDA Pre-ANDA meetings, Scientific Advice, or other health authority interactions would be an advantage.

Key Competencies

• Strong global regulatory strategy and regulatory science orientation.
• Sound understanding of peptide and complex generic product development challenges.
• Excellent dossier review and technical writing capabilities.
• Strong analytical and regulatory problem-solving skills.
• Ability to interpret evolving regulatory requirements and translate them into actionable development or submission strategies.
• Proven capability to manage multiple products, markets, submissions, and competing timelines.
• Strong cross-functional stakeholder management and influencing skills.
• Ability to independently drive complex regulatory assignments and elevate critical risks appropriately.
• Strong written and verbal communication skills.
• Demonstrated ownership, accountability, and attention to detail.