DRA

Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and reguiations.API Equipment Handling.

Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation

Good Exposer On Life Cycle Management, Handling Post Approval & Pre approval, Knowledge on MAA (Marketing Authorization Application), Experience in CMC, Variations.

Novartis is hiring an International Program Regulatory Director IPRD in Hyderabad. Apply if you have exp in global/regional regulatory roles and expertise in drug registration strategies.

Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.

Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives 

PharmD/MS in a scientific discipline or equivalent education and related experience. Masters degree in RA/QA discipline, a plus.

Academic degree in Pharmacy MPharm or PhD, with preferably specialization in Regulatory Affairs or Pharmaceutics.

Demonstrated understanding of pharmaceutical manufacturing, analytical testing, and quality assurance. managing CMC Regulatory submissions for small molecules/vaccines/biologics