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 Assistant Manager Regulatory Affairs an aggressive / dynamic Regulatory Affairs Professional.
This position is based at our R&D center at Turbhe Navi Mumbai and will report to the Sr. Manager / Head - Regulatory Affairs
The remuneration package will be commensurate with the incumbent's professional experience and will be in line with market standards.
Essential skills and experience:
- The incumbent must have min. 10 years experience in the pharmaceutical industry with a minimum of 6-8 years experience handling Regulatory compliance across the Brazil market.
- Develop and execute regulatory strategies for new registrations in Brazil market.
- Provide regulatory input during product development, CMC, labelling, and clinical/medical strategy discussions.
- Prepare/coordinate dossiers (CTD/eCTD) including Module 1-5 requirements.
- Compile, review, and submit applications via Brazil-ANVISA systems; track and respond to queries/deficiencies within defined timelines.
- Partner with CMC, Quality, Supply Chain, Medical, Pharmacovigilance, and Commercial to align regulatory strategy.
- Prepare, coordinate, and attend meetings with customer / ANVISA; support interactions with authorities as and when required.
- Ensure compliance with Brazil labeling requirements (SmPC/IFU/PIL), serialization/traceability, and artwork controls.
- Maintain up-to-date knowledge of Brazilian regulatory frameworks, guidance, and timelines.
- Ensure adherence to internal SOPs, GDP, data integrity, and audit-readiness.
- Maintain accurate submission trackers, registration databases, regulatory archives, and regulatory intelligence logs.
Other responsibilities:
- Bachelor's/Master's in Pharmacy, Life Sciences, or related field.
- 68+ years of regulatory experience in pharmaceuticals with hands-on ANVISA submissions.
- Strong knowledge of Brazilian regulatory framework: new drug registration, generics, labeling, GMP certification alignment, AMV, stability, BE/CDP requirements etc.
- Proficiency with CTD/eCTD structure; understanding of CMC and PV interface.
- Excellent project management, attention to detail, and cross-functional communication skills.
