Manager​/Sr Manager Regulatory Affairs– US Markets

Position: Manager / Sr Manager Regulatory Affairs– US Markets
UMEDICA 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 founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.

We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

As part of our further expansion and growth plans, we are looking to hire   Manager / Sr Manager  Regulatory Affairs– US Markets  in  Regulatory Affairs  department.

This position is based at our  R&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs.

The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards.

Key Responsibilities:

Regulatory Submissions:
Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA
Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports)
Ensure compliance with current USFDA regulations and guidance documents
FDA Interactions:
Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings)
Participate in and support FDA meetings as the regulatory lead
Handle Controlled Correspondence with the FDA for product development and regulatory strategy
Product Expertise:
Provide regulatory support for  complex formulations , including  injectables and liquid dosage forms
Collaborate with R&D, QA, QC, and manufacturing teams to ensure regulatory alignment throughout the product lifecycle
Leadership & Communication:
Lead a team of regulatory professionals, providing guidance, training, and performance management
Communicate effectively with internal stakeholders and external regulatory bodies

Qualifications &

Experience:

Master’s degree in Pharmacy
13–15 years of experience in US Regulatory Affairs with a proven track record in ANDA/NDA submissions
Hands-on experience with FDA meetings, Controlled Correspondence, and post-approval changes
Strong understanding of injectables, liquid dosage forms, and complex generics
Excellent written and verbal communication skills
Demonstrated leadership and team management capabilities