India's DMPLOI - Jobs & Networking AppSkymap Pharmaceuticals Pvt. Ltd., an EU-GMP certified pharmaceutical organization and a Great Place to Work certified company, has announced an exciting career opportunity for the position of General Manager (GM) – Regulatory Affairs. This leadership role is ideal for experienced regulatory professionals who possess deep expertise in global regulatory compliance, product registration, dossier management, and regulatory strategy development.
The company is seeking a dynamic professional who can lead regulatory operations, ensure compliance with international guidelines, and support business expansion through effective regulatory planning and execution.
Position Overview
Designation: GM – Regulatory Affairs
Location: Faridabad, India
Industry: Pharmaceutical Manufacturing
Experience Required: 15–20 Years
Qualification: Bachelor’s or Master’s Degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. Regulatory Affairs certification is preferred.
Key Responsibilities
The selected candidate will be responsible for:
Developing and implementing regulatory strategies for product registrations and market expansion.
Ensuring compliance with national and international regulatory requirements.
Managing regulatory submissions, registrations, renewals, and approvals.
Overseeing dossier preparation, compilation, review, and submission activities.
Driving product registration and lifecycle management across global markets.
Collaborating with Quality Assurance, Manufacturing, R&D, Packaging Development, Marketing, and Supply Chain teams.
Leading and mentoring the Regulatory Affairs team.
Supporting regulatory inspections, audits, and documentation management.
Monitoring regulatory updates and implementing necessary compliance actions.
Essential Skills
The ideal candidate should possess strong expertise in:
Regulatory Compliance
Dossier Submission
Product Registration
Regulatory Intelligence
Team Leadership
Regulatory Documentation
Cross-Functional Coordination
Global Regulatory Strategy
Why Join Skymap Pharmaceuticals?
Skymap Pharmaceuticals offers a professional environment focused on growth, innovation, and employee development. Benefits include:
Career Growth Opportunities
Professional Learning & Development
Competitive Compensation
Collaborative Work Culture
Exposure to Global Regulatory Markets
Career Impact
The GM – Regulatory Affairs position plays a critical role in ensuring successful product registrations, maintaining regulatory compliance, and supporting the company’s international growth objectives. Professionals with extensive regulatory experience and leadership capabilities can significantly contribute to organizational success while advancing their careers in pharmaceutical regulatory management.
Technical FAQs
1. What is the primary role of a GM – Regulatory Affairs in a pharmaceutical company?
A GM – Regulatory Affairs oversees regulatory strategy, product registrations, dossier submissions, compliance management, and interactions with global regulatory authorities to ensure products meet legal and quality requirements.
2. What types of regulatory dossiers are commonly managed in this role?
The role typically involves managing CTD/eCTD dossiers, DMFs (Drug Master Files), product registration dossiers, variation filings, renewals, and post-approval regulatory submissions.
3. Why is regulatory intelligence important for pharmaceutical organizations?
Regulatory intelligence helps companies track changing regulations, identify compliance risks, adapt registration strategies, and maintain uninterrupted market access across different countries.
4. What global regulatory guidelines should a senior regulatory professional be familiar with?
A senior regulatory professional should have knowledge of ICH guidelines, WHO regulations, US FDA requirements, EMA standards, MHRA regulations, GCC guidelines, and other country-specific regulatory frameworks.
5. How does Regulatory Affairs contribute to product lifecycle management?
Regulatory Affairs supports the entire product lifecycle by managing approvals, post-approval changes, renewals, labeling updates, compliance activities, and market expansion registrations to ensure continued product availability.
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