Director Regulatory Affairs- US post approvals
5 days ago
Opening with a leading Pharma company for their office in Navi Mumbai
Role: Director Regulatory Affairs - US post approvals
Experience: 15 Years+
Role & responsibilities :
Essential Duties & Responsibilities:
- Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations.
Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including:
CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences
Serve as the primary regulatory authority on post-approval matters, providing expert guidance to executive leadership and cross-functional teams.
- Lead regulatory assessments and decision-making for complex changes, including site transfers, formulation changes, alternate APIs, etc.
- Establish and maintain strong relationships with FDA project managers.
- Monitor and interpret evolving FDA regulations, guidances, and enforcement trends; proactively adapt strategies and internal processes.
- Develop and implement regulatory policies, SOPs, and training programs to ensure consistent and compliant practices across the organization.
- Lead, mentor, and develop a high-performing regulatory team, fostering a culture of accountability, innovation, and continuous learning.
- Represent Regulatory Affairs in global governance forums, strategic planning sessions, divestment assistance and support of internal initiatives.
- Initiate/manage notices of commercial launch and product obsoletion, as well as updates to the Orange Book.
Position Requirements:
- Pharm D or M. Pharma in a scientific discipline.
- Minimum 15+ years of pharmaceutical industry experience, with at least 10+ years in U.S. Regulatory Affairs focused on managing the lifecycle of generic drug products.
- Proven leadership (8+ years in a supervisory role) in independently managing a large regulatory team, as well as a large and diverse post-approval portfolio consisting of various, globally manufactured dosage forms and complex supply chains.
- Deep expertise and applied knowledge of FDA regulations (21 CFR , ICH guidelines, and eCTD submission standards.
- Experience with regulatory systems (e.g., Veeva, TrackWise) and electronic document management systems (e.g. Wisdom, Glorya, Livelink, Knowledgetree).
- Demonstrated success in leading regulatory strategy, agency interactions, and lifecycle management for ANDAs/NDAs.
- Strong business acumen and ability to align regulatory strategies with commercial and operational objectives, while maintaining regulatory compliance.
- Demonstrates a basic understanding of pharmaceutical drug development.
- Demonstrated/proven track record of FDA interactions, as well as negotiation and influencing skills.
- Demonstrates excellent verbal and written communication skills.
- Experience working in a matrixed, multinational environment, as well as with third parties.
- Experience with regulatory intelligence, policy shaping, and industry advocacy is a plus.
- Lean Six Sigma certification, or other accreditation related to improving business processes is a plus.
Interested candidate share resume
-
Vacancy for Regulatory Affairs at Delhi Ncr
2 weeks ago
Mumbai, India RIGHT STAFF Full timeGreetings from Right Staff One of our client who are into Medical Devices Are looking for a Regulatory Affairs person at Delhi NCR Job Description - Designation - Regulatory Affairs/QA Affairs Time - Day Shift Location - Delhi NCR **Responsibilities**: - 1. Identify regulatory and post market requirements for new products or product enhancements early...
-
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was...
-
Manager / Sr Manager Regulatory Affairs– US Markets
22 hours ago
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was...
-
Manager / Sr Manager Regulatory Affairs– US Markets
14 hours ago
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was...
-
navi mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Manager / Sr Manager Regulatory Affairs– US Markets
21 hours ago
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Manager / Sr Manager Regulatory Affairs– US Markets
15 hours ago
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Manager / Sr Manager Regulatory Affairs– US Markets
22 hours ago
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
