Manager – Regulatory Affairs (CMC) – Mumbai, India
Experience: Minimum 10 Years | Category: Regulatory Affairs | Employment Type: Full-Time
Company Overview:
Join a leading pharmaceutical organization committed to ensuring regulatory compliance, scientific integrity, and innovation in product development. The Manager – Regulatory Affairs (CMC) will play a strategic role in managing product registrations, submissions, and cross-functional regulatory activities, ensuring that products comply with regional and global regulatory requirements throughout their lifecycle.
Role Overview:
The Manager – Regulatory Affairs (CMC) is an experienced individual contributor responsible for managing complex product registrations, regulatory strategies, and compliance activities. This role involves close collaboration with internal project teams, affiliates, and regulatory agencies to ensure smooth product lifecycle management, risk mitigation, and regulatory adherence.
Key Responsibilities:
1. Product Registrations & Submissions:
Lead and manage product registration activities, preparing and requesting documentation for complex filings.
Monitor regulatory activities and timelines using project management skills to ensure deadlines are met.
Prepare registration packages for routine filings and responses to deficiency letters.
Identify and collect necessary data and seek expert guidance for complex filings.
2. Cross-Functional Collaboration:
Represent Regulatory CMC in project meetings and communicate regulatory positions.
Monitor and communicate actual versus planned regulatory activities and timelines.
Identify and communicate risks and issues impacting project progression.
3. Affiliate Coordination:
Maintain strong working relationships with regional product leads and affiliate colleagues to ensure alignment on regulatory activities.
4. Compliance Management:
Assess and approve change requests, updating regulatory files accordingly.
Stay updated on legislation and developments to ensure products remain compliant throughout their lifecycle.
5. Regulatory Strategy & Process Improvement:
Develop Regulatory CMC strategies for assigned products and projects.
Identify, communicate, and mitigate regulatory risks.
Suggest process improvements, support development of position papers, and create work aids.
6. Health Agency Interaction & Licensing Reviews:
Attend health agency meetings as required.
Provide CMC regulatory support for licensing due diligence activities.
Technical Competencies:
Strong knowledge of technical/scientific principles relevant to assigned products.
General knowledge of global and regional regulatory requirements.
Specialist knowledge of country-specific regulatory and product-class requirements.
Core Competencies:
Adaptability: Prioritize tasks effectively, re-assess commitments, and solve problems proactively.
Initiative: Learn new aspects of the business, anticipate challenges, and seek constructive feedback.
Innovation: Identify unique approaches to address work challenges.
Integrity: Deliver high-quality results, meet deadlines, and provide accurate, impartial information.
Teamwork: Collaborate actively with colleagues to achieve shared goals.
Leadership Competencies:
Set vision and strategy for regulatory CMC activities, ensuring stakeholder alignment.
Mentor junior team members and provide training in areas of expertise.
Drive results through efficient decision-making and goal completion.
Promote an open environment for knowledge sharing and constructive feedback.
Educational Qualification:
Bachelor’s Degree in Pharmacy, Biology, Chemistry, Pharmacology, or related field.
Experience Requirements:
Minimum 10 years of experience in Regulatory Affairs, R&D, Manufacturing, or related pharmaceutical/biotech roles.
Proven experience managing complex product registrations, submissions, and cross-functional regulatory activities.
Why Join Us:
Work in a strategic regulatory role with global exposure and responsibility.
Collaborate with cross-functional teams, affiliates, and regulatory authorities to drive compliance and product approvals.
Contribute to process improvement initiatives and develop leadership skills within regulatory affairs.
Apply Now: Advance your career as a Manager – Regulatory Affairs in Mumbai and play a critical role in ensuring global regulatory compliance and scientific excellence.
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