Role & responsibilities

The General Manager Drug Regulatory Affairs will be responsible for leading the Regulatory Affairs function and driving global regulatory strategies to support product registrations, approvals, and lifecycle management across regulated and semi-regulated markets. The incumbent will ensure timely preparation, review, and submission of regulatory dossiers while maintaining compliance with international regulatory requirements and business objectives.

The role requires extensive experience in pharmaceutical product development, regulatory submissions, health authority interactions, and post-approval lifecycle management, particularly for injectable formulations.

Key Responsibilities

Regulatory Strategy & Planning

- Develop and implement global regulatory strategies to support product development, registration, and commercialization.
- Provide strategic regulatory guidance to cross-functional teams including R&D;, Quality Assurance, Manufacturing, Clinical, Pharmacovigilance, and Business Development.
- Assess regulatory risks and opportunities and formulate mitigation plans to ensure timely approvals.
- Monitor evolving global regulatory requirements and ensure organizational preparedness and compliance.

Regulatory Submissions & Approvals

- Lead the preparation, review, compilation, and submission of dossiers in CTD/eCTD format for regulated and semi-regulated markets.
- Oversee submission activities for:
- INDs (Investigational New Drug Applications)
- CTAs (Clinical Trial Applications)
- NDAs/sNDAs
- MAAs (Marketing Authorization Applications)
- Product Variations
- Renewals and Lifecycle Management Activities

- Ensure high-quality preparation of regulatory documents including:

- Module 2 Summaries
- Investigator Brochures
- Clinical Study Reports
- Risk Management Plans
- Regulatory Justifications and Responses

Health Authority Interactions





- Lead and coordinate communications and meetings with regulatory authorities including USFDA, EMA, MHRA, Health Canada, TGA, GCC, and other international agencies.
- Manage responses to deficiency letters, regulatory queries, and commitments within stipulated timelines.
- Represent the organization during regulatory inspections, audits, and authority interactions.

Lifecycle Management & Compliance

- Oversee post-approval regulatory activities including variations, renewals, annual reports, site transfers, product changes, and compliance maintenance.
- Ensure adherence to applicable regulatory guidelines, company SOPs, and global compliance requirements.
- Maintain regulatory intelligence systems and communicate regulatory updates to relevant stakeholders.

Team Leadership & Development

- Lead, mentor, and develop the Regulatory Affairs team to achieve departmental and organizational objectives.
- Establish performance metrics, departmental goals, and development plans for team members.
- Develop and implement departmental SOPs, policies, and best practices.
- Foster a culture of compliance, accountability, teamwork, and continuous improvement.

Cross-Functional Collaboration

- Collaborate with internal stakeholders to ensure regulatory requirements are incorporated throughout product development and commercialization processes.
- Support business expansion initiatives through regulatory assessments and strategic market-entry planning.
- Participate in due diligence activities, product acquisition evaluations, and licensing opportunities.

Required Qualifications

- Master's Degree in Pharmacy, Life Sciences, Biotechnology,



Chemistry, or related scientific discipline.
- M.Pharm, Ph.D., or equivalent advanced qualification preferred.
- Regulatory Affairs Certification (RAC) will be an added advantage.

Experience Requirements

- Minimum 20-30 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Demonstrated experience in pharmaceutical product development, regulatory submissions, and approvals.
- Hands-on experience in preparation and submission of INDs, CTAs, NDAs, MAAs, and lifecycle management dossiers.
- Minimum 35 years of experience handling European regulatory procedures, variations, renewals, and post-approval submissions.
- Experience with injectable products and sterile manufacturing facilities is highly preferred.
- Exposure to antibiotics and complex pharmaceutical products will be an added advantage.
- Experience working with global regulatory agencies and multinational regulatory environments preferred.

Key Competencies

- Strong knowledge of global regulatory guidelines and requirements.
- Expertise in CTD/eCTD dossier preparation and lifecycle management.
- Strong leadership and people management skills.
- Excellent project management and organizational abilities.
- Effective stakeholder management and negotiation skills.
- Solid analytical and problem-solving capabilities.
- Excellent verbal and written communication skills.
- Ability to manage multiple projects and deadlines in a dynamic environment.

Key Performance Indicators (KPIs)

- Timely submission and approval of regulatory dossiers.
- Successful closure of regulatory queries and deficiencies.
- Compliance with global regulatory requirements and audit readiness.
- Effective management of product lifecycle activities.
- Achievement of departmental goals and business objectives.
- Team development and succession planning.

📌 Head Regulatory Affairs (Panchkula)
🏢 Venus Remedies (VRL)
📍 Panchkula