Senior Manager - Project Management

About Alkem:

Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the top five pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India.

Key Responsibilities:

1. Develop and implement Emerging Market, strategies for In-license product registration, variations, renewals, and life-cycle management for Inlicencing products.

2. Ensure compliance with Emerging Market regulatory guidelines.

3. Manage regulatory submissions (CTD, ACTD, eCTD dossiers) and timely responses to authority queries for Inlicensing products in coordination with DRA.

4. Liaise with country RA teams & health authorities, external consultants, and industry associations for smooth regulatory interactions for Inlicensing products.

5. Monitor evolving regulatory environments and assess impact on business.

6. Ensure product labeling, packaging, and promotional material comply with applicable regulations.

7. Develop project timelines, budgets, and resource plans, ensuring on-time delivery.

8. Coordinate between R&D, QA, QC, Manufacturing, Supply Chain, and Commercial teams to ensure project alignment.

9. Track project risks, implement mitigation strategies, and report progress to leadership.

10. Drive efficiency in regulatory & project processes through digital tools, dashboards, and governance systems.

Key Skills & Competencies:

1. In-depth knowledge of global regulatory frameworks (SFDA / GCC / PICs / BPOM / EAEU)

2. Proven track record of successful regulatory submissions and project execution.

3. Excellent leadership, stakeholder management, and communication skills.

4. Ability to manage multiple projects under tight timelines.

Qualifications & Experience:

1. M.Pharm / M.Sc. (Pharmaceutical Sciences, Regulatory Affairs, or related field).

2. 10–14+ years of experience in pharmaceutical regulatory affairs and project management.

3. Demonstrated experience in global submissions and product lifecycle management.

4. Prior experience leading a regulatory/project team at a cluster or regional level preferred.