Regulatory affairs

The candidate will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders. The candidate will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department.

CORONA Remedies Pvt. Ltd. Our journey started in 2004, with a commitment to creating a better quality of health for all by being at the forefront of research, manufacturing and marketing of high quality products.

The Senior Specialist, Expert License Management prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authorities requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach.

B.Pharm / M.Pharm; Compile, review and timely submission of Deficiencies responses as received from Health Canada. Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines.

Tevas Global Regulatory Affairs Policy and Intelligence team is at the forefront of regulatory policy and intelligence, transforming complex regulatory landscape updates into actionable insights to inform regulatory strategy and cross-functional strategic decision-making.

Support affiliates in updating local requirements based on regulatory agencies guidance and input from affiliates, distributors. Manage working relationships with key stakeholders. Ensure compliance with regulatory requirements and provide strategic product direction to teams.

PhD, MS, BS in relevant functions in the Pharmaceutical, Biotechnology Industry, or equivalent. Subject matter expertise in regulatory affairs and related activities.

Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.

Coordinating with cross-functional teams for data collection and dossier preparation. Handling regulatory queries and responses from global health authorities. Ensuring compliance with ICH guidelines, USFDA, EDQM, and other international regulatory standards