Job Description

Associate Director, Regulatory Affairs

Registration of products for the Indian Market. To ensure compliance to all applicable laws and regulations in respect of Own and Contract Manufacturing of Company’s product. To ensure full Compliance to Internal Compliance policy. Development of Dossiers for export and local market. To liaise with concerned authorities for the above. To represent company in various Industry Forums. Strategic initiatives for new product developments through gap analysis. Strategic initiatives by identifying opportunities for improving the market share for company’s business.

ROLE RESPONSIBILITIES

Primary responsibilities critical to the performance of the role.
• Registration of Imported Pharmaceuticals and Vaccines.

• Registration of local Biological & pharma Products.

• Development of dossiers of local Biological and Pharmaceutical products for Export markets.

• Renewal & maintenance of all licenses - GMP/Manufacturing/Wholesale & others owned by company & CMO.





• Regulatory compliance to import products for clinical trials & CDTL testing.

• Providing requested documents for registration of products in Export markets & approving all artworks & other requisites on timely basis.

• Approval of artworks on imported & local products in accordance with country specific requirements in co-ordination with BU Heads and International Packaging.

• Initiation and co-ordination of Toxicity studies on Pharmaceutical Formulations and raw materials.

• Maintenance of Archives as a disciplined, secure & confidential record keeping

• Ensuring compliance with EHS, OHSAS and ISO standards in RA department.

• Plan and organize with International RA departments by providing current registration (document) requirements of India.

• Obtain required documents from local or international colleagues and submit applications for registration of products.

• To co-ordinate with Marketing for priorities and liaison Manager in Delhi for Registratio

📌 Associate Director (Pune)
🏢 Msd
📍 Pune