Job Title: Sr. Manager – Regulatory Affairs – CMC – US Market
Location: Gurgaon, India
Business Unit: Clinical Development
Company: Sun Pharmaceutical Industries Ltd
Employment Type: Full-Time
Experience Required: 12–16 Years
Education Required: M.Pharm
Senior Manager – Regulatory Affairs (CMC) – US & Advanced Markets
Sun Pharmaceutical Industries Ltd is seeking a seasoned Regulatory Affairs professional to lead Chemistry, Manufacturing and Controls (CMC) strategy for branded products targeting the US and other advanced markets including EU and Canada. This leadership role is responsible for end-to-end CMC regulatory lifecycle management, health authority interactions, and cross-functional regulatory strategy execution.
This position is ideal for regulatory experts with strong NDA experience, deep understanding of US FDA CMC requirements, and demonstrated success in managing complex global submissions.
Role Overview
The Sr. Manager – Regulatory Affairs (CMC) will act as the CMC Regulatory Product Lead, providing strategic regulatory direction across development, submission, approval, and post-approval lifecycle management. The role requires close collaboration with R&D, manufacturing, quality, analytical development, and global regulatory teams to ensure successful approvals and sustained market supply.
The candidate must possess strong technical expertise in NDA filings, regulatory risk assessment, and agency communications within regulated markets.
Key Responsibilities
Regulatory CMC Leadership
Serve as CMC Regulatory Lead for branded products under development for US and other advanced markets.
Provide strategic CMC regulatory guidance within cross-functional development teams.
Develop, review, and execute CMC Regulatory Strategy Documents for complex products.
Assess regulatory risks and define mitigation strategies to enhance probability of approval.
Global Regulatory Submissions & Lifecycle Management
Lead preparation and submission of PIND, IND, CTA, NDA, MAA, supplements, and annual reports.
Ensure timely lifecycle management submissions to maintain uninterrupted product supply.
Manage agency background packages and responses to US FDA and other health authority queries.
Support variation filings and post-approval regulatory changes.
Health Authority Interactions
Lead communication with regulatory agencies in US and EU markets.
Critically review scientific data to ensure clear technical justifications and defensible regulatory arguments.
Prepare strategic responses to deficiency letters and information requests.
Due Diligence & Portfolio Support
Provide regulatory leadership for product in-licensing, due diligence assessments, divestments, and product withdrawals.
Support evaluation of new technologies and innovation initiatives within the organization.
Cross-Functional Collaboration
Work closely with manufacturing, analytical development, quality assurance, and supply chain teams.
Demonstrate comprehensive understanding of CMC development and regulatory impact.
Mentor junior regulatory team members where required.
Lead cross-functional discussions in R&D CFT environments.
Compliance & Governance
Ensure all regulatory activities are conducted in strict compliance with global regulatory requirements and internal SOPs.
Maintain audit readiness and regulatory documentation integrity.
Technical Skills & Competencies
Hands-on expertise in preparation and review of CMC dossiers for US FDA and EU authorities.
Strong knowledge of NDA/MAA regulatory pathways and submission frameworks.
Proven ability to evaluate complex scientific data and present clear regulatory arguments.
Excellent written and verbal communication skills in English.
Strong negotiation, leadership, and stakeholder management capabilities.
Ability to manage changing priorities and complex regulatory challenges.
Sound understanding of manufacturing, analytical, and quality systems within pharmaceutical development.
Required Qualifications
M.Pharm in Pharmaceutical Sciences.
12–16 years of hands-on experience in Regulatory Affairs with strong CMC exposure.
Demonstrated experience leading NDA submissions for US market.
Proven experience working within R&D cross-functional teams.
Prior team management or mentoring experience preferred.
Proficiency in English; additional language skills are an advantage.
Travel Requirement
Travel may be required based on project needs and regulatory engagements.
Why Join Sun Pharmaceutical Industries Ltd
Sun Pharma is one of the world’s leading specialty generic pharmaceutical companies with a strong presence in regulated and emerging markets. This role offers the opportunity to lead high-impact US regulatory CMC programs, engage with global health authorities, and contribute to successful branded product approvals in advanced markets.
Disclaimer
This job description reflects the general nature and scope of responsibilities associated with this role. It is not an exhaustive list of duties and may evolve based on business requirement.
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