Regulatory affairs

Forecast inventory and schedule production. Raise material orders and coordinate deliveries, Liaise with departments for protect execution. Prepare cost sheets and stock statements.

Experience in pharmaceutical regulatory affairs, including leadership roles and expertise in global regulatory requirements and guidelines including FDA, EMA, and ICH regulations.

Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority.

You will be responsible for preparation, review and submission of Dossier in ANZ and Emerging Markets as per the applicable regulatory guidance in Emerging Markets. 

Responsible for Preparation of Regulatory Documents for submission to Indian Regulatory Authorities. Experienced in handling, management and expansion of product portfolios, markets/ territories.

PhD in any area of Life Sciences / Biotechnology / Agri / Plant Sciences / Regulatory Sciences / Pharma / Management / Public Policy or any other related area. 

B.Pharm / M. Pharm with experience in R&D or a related role. Strong Analytical, Problem-solving, and Critical thinking skills., Excellent Communication and Coordination skills.

This role is responsible for managing and overseeing critical aspects of the production process, ensuring adherence to quality standards and regulatory compliance.

Sunrise Laboratories as an Ayurvedic Finished Product formulation in the year 1988, Sunrise become a Sunrise Remedies Pvt. Ltd. in 1996.