Regulatory Affairs Job at Alkem Laboratories
Alkem Laboratories is hiring a Head – Medico-Regulatory Affairs (Domestic & International) and International Medical Affairs (Medico-Marketing) at the General Manager or Deputy General Manager level. The regulatory affairs job calls for an MBBS/MD qualification and 12–18 years of relevant pharmaceutical experience.
Job Details:
- Position: Head – Medico-Regulatory Affairs (Domestic & International) and International Medical Affairs (Medico-Marketing)
- Designation: General Manager (GM) / Deputy General Manager (DGM)
- Department: Medical Affairs
- Industry: Pharmaceuticals
- Reporting to: Senior Vice President – Medical Affairs & Pharmacovigilance
Regulatory Affairs Job Description:
To provide strategic, scientific, medical and regulatory leadership for domestic and international pharmaceutical businesses, ensuring compliance with applicable regulatory requirements, scientific accuracy of product information, and effective medical support for international marketing activities.
The position will oversee medico-regulatory activities across India and international markets, while driving international medical affairs and medico-marketing initiatives to support product registrations, launches, lifecycle management and commercial growth.
Key Responsibilities:
Medico-Regulatory Affairs – Domestic (India)
- Lead medico-regulatory activities in compliance with CDSCO requirements, applicable provisions of the Drugs and Cosmetics Act and Rules, and NDCT Rules, 2019.
- Provide medical and scientific inputs for new drug applications, additional indications, dosage forms, fixed-dose combinations and product lifecycle management.
- Review and approve prescribing information, package inserts, product monographs, promotional materials and medical claims.
- Provide medical justification and clinical evidence for regulatory submissions and responses to regulatory queries.
- Coordinate with Regulatory Affairs, R&D, Clinical Research, Pharmacovigilance, Quality and Marketing.
- Ensure compliance with applicable Indian requirements governing pharmaceutical promotional communications.
- Lead, make presentations and coordinate with stakeholders for presentations to SECs, ICMR, RCGM/ DBT (if applicable), grant committees such as BIRAC, PRIP and other relevant committees from time to time.
Medico-Regulatory Affairs – International
- Provide medical and scientific support for product registrations across regulated, semi-regulated and emerging international markets.
- Review clinical and medical components of CTD/eCTD dossiers, including relevant clinical summaries, overviews and supporting literature.
- Prepare clinical justifications, benefit-risk assessments, literature reviews and medical responses to regulatory deficiencies.
- Support regulatory submissions, renewals, variations, label updates and additional indication applications.
- Review and harmonise prescribing information, SmPCs, patient information leaflets and medical claims according to country-specific requirements.
- Collaborate with international Regulatory Affairs teams and business partners to address medical and clinical regulatory queries.
- Represent medical affairs in regulatory meetings across regulated and emerging markets.
International Medical Affairs & Medico-Marketing
- Develop and implement medical affairs strategies supporting international pharmaceutical business operations.
- Provide scientific and medical inputs for new product identification, evaluation, positioning and launches.
- Develop scientifically validated product monographs, clinical presentations, medical detailing materials, FAQs and training modules.
- Review international promotional and scientific communication materials for accuracy, balance, substantiation and local compliance.
- Support international marketing teams with therapeutic-area insights, clinical evidence and product differentiation strategies.
- Conduct medical training for international marketing teams, country managers, distributors and business partners.
- Provide medical support for advisory boards, scientific meetings, CMEs, KOL engagements and international conferences, in accordance with applicable requirements.
- Support evidence-based product positioning and lifecycle management across therapeutic portfolios.
- Conduct and coordinate local clinical studies in various countries especially ROW countries, to support local product registration and marketing support.
Medical Information and Scientific Communication
- Establish processes for responding to medical and scientific enquiries from international markets.
- Develop standard medical responses and scientific communication documents.
- Conduct critical literature evaluation and prepare evidence summaries.
- Support medical review of scientific publications, abstracts and educational content.
- Ensure appropriate handling and escalation of adverse-event and product-quality information received through medical enquiries.
Cross-Functional Collaboration
- Partner with International Business, Domestic Marketing, Regulatory Affairs, R&D, Clinical Development and Pharmacovigilance.
- Support portfolio evaluation and business development through medical due diligence.
- Provide medical inputs for product licensing, in-licensing and market expansion opportunities.
- Coordinate with external medical experts, consultants and international business partners.
Leadership, Governance and Compliance
- Lead and develop the medico-regulatory and international medical affairs team.
- Establish SOPs, review processes, approval workflows and compliance controls.
- Ensure timely completion of medical reviews, regulatory responses and medico-marketing deliverables.
- Maintain audit-ready documentation and appropriate medical approval records.
- Prepare departmental performance reports and ensure efficient allocation of resources.
Eligibility Criteria for Regulatory Affairs Job:
Educational Qualifications
- MBBS / MD (Pharmacology or other relevant clinical speciality) preferred.
- Additional qualifications in Clinical Research, Regulatory Affairs, Pharmaceutical Medicine or Management desirable.
Experience
- 12–18 years of relevant experience in the pharmaceutical industry, depending on designation.
- Significant experience in medico-regulatory affairs, medical affairs and pharmaceutical medico-marketing.
- Exposure to domestic and international regulatory requirements.
- Experience supporting international pharmaceutical business operations and product registrations.
- Prior Team Leadership And Cross-functional Management Experience Preferred.
Required Skills:
- Strong knowledge of pharmaceutical medicine and clinical pharmacology.
- Understanding of CDSCO and international regulatory frameworks.
- Expertise in medical review of promotional and non-promotional materials.
- Strong scientific writing, literature evaluation and medical communication skills.
- Understanding of CTD/eCTD clinical documentation and benefit-risk evaluation.
- Strategic thinking, stakeholder management and leadership capabilities.
- Ability to manage multiple therapeutic areas and international markets.
Additional Information:
Key Performance Indicators (KPIs)
- Domestic medico-regulatory: Timeliness and quality of medical reviews and regulatory responses
- International medico-regulatory: On-time medical dossier inputs and deficiency responses
- Medico-marketing: Turnaround time and compliance of promotional material approvals
- Product launches: Timely delivery of medical launch support
- Scientific training: Training coverage, completion and effectiveness
- Medical information: Response timelines and scientific quality
- Compliance: Audit findings, documentation completeness and corrective actions
- Team management: Productivity, capability development and achievement of departmental objectives
Recommended Organisational Positioning
- Domestic Medico-Regulatory
- International Medico-Regulatory
- International Medical Affairs & Medico-Marketing