Regulatory Affairs Officer

Description:

Don Valley Pharmaceutical is a dynamic and innovative pharmaceutical company committed to developing and delivering high-quality healthcare solutions. With a focus on research, development, and manufacturing, we strive to make a positive impact on global health. As we continue to grow, we are seeking a highly motivated and skilled Regulatory Affairs Specialist to join our team.

Position Summary: The Regulatory Affairs Specialist will play a crucial role in ensuring compliance with regulatory requirements and facilitating the successful approval and commercialization of our pharmaceutical products. The successful candidate will collaborate with cross-functional teams, regulatory agencies, and other stakeholders to navigate regulatory processes and maintain a high standard of regulatory compliance.

Responsibilities:

Ø Preparation of dossiers on Form 5

Ø Preparation of dossiers on Form 5 F as per CTD Format of DRAP

Ø Renewal of Registrations

Ø cGMP certificate from DRAP

Ø Renewal of Drug Manufacturing License

Ø Maintaining the records of all the documents form DRAP

Ø Implementation of drug pricing policy

Ø All matters relevant to pricing

Ø Implementation of price increase as per new SRO

Ø PQCB/Health Department letter response

Ø NIH letters responses

Ø Documentation of NOC for export purpose

Ø Documentation for issuance of COPP and FSC for export

Ø Verification of certificate of analysis for finished product for export

Ø Documentation for NOC for export purpose