Bachelors degree in Life Sciences, Pharmacy, Biotechnology, Regulatory Affairs, or related discipline. Lead, coach, and develop a team of Regulatory Affairs professionals supporting APAC lifecycle management activities
Applications are invited for the vacant post in Shirpur Education Society’s H. R. Patel Institute of Pharmaceutical Education & Research, permanent non grant basis institute.
Contribute to the preparation (including authoring, where relevant) and delivery of simple regulatory maintenance submissions and, with experience, increasingly complex submissions from a global and/or regional perspective.
To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.
Enzene Biosciences is a biopharmaceutical CDMO focused on biosimilars and biologics. Our EU-GMP certified facilities in Pune support Drug Substance and Drug Product development and manufacturing, and we also have a presence in New Jersey, USA. We partner with clients worldwide to bring affordable biologics to patients globally.
Post : CMC Regulatory Affairs (Biologics) – Executive to Manager
Support submission publishing readiness by ensuring correct document metadata, naming conventions, formatting, and version control for Module 1 documents prepared and stored in the company electronic document management systems.
B&S Group, our mission is to create daily value for customers. In the fast-paced pharmaceutical world, more than just supplying products is needed. Excellence, innovation, and exceptional service truly make a difference.
The person will be responsible for overseeing strategy relating to obtaining, managing and maintaining product Marketing Authorizations and support Clinical Trial Authorizations (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs
The role coordinates cross-functional activities from due diligence through filing, approval and commercialization, ensuring successful integration of licensed products into the company's portfolio.