Senior Manager - Regulatory Affairs - Biologics

Sr. Manager - Regulatory Affairs - Biologics,

Experience - 10/10+ years of experience.

Location- Mumbai

The JD of the role is attached below

Product Development Regulatory support

- Work with RDPM to highlight risks to the project and suggest risk mitigation strategies

- Provide recommendations for the product development activities in line with current regulatory expectations

- Review all documents related to product development including CMC/preclinical/clinical development

Regulated market submissions

- Prepare and submit applications for (pre)-clinical trial/marketing authorizations dossiers to customer / Health Authorities and subsequently follow-up for approval.

- Archive all communications with customers, consultants and regulatory agencies

- Review content sufficiency and accuracy of (pre)-clinical trial operational plans, deviations, proposals, protocol, IB

- Support for medical device development, including assistance in premarket approval (PMA) submissions to FDA

- Provide, review and approve the content for product information (SmPC/PIL/Label)

- Send notification to customers for changes

Domestic/Emerging market submissions and support

- Submit Registrations, Re-registrations, (Pre)Clinical trial applications, amendment and Tender (country specific) dossiers

- Initiate request for preparing separate set of documents basis the targeted market by making checklist and sharing with cross functional departments

- Keep track of test licenses/manufacturing licenses/GMP certifications and ensure renewal of the same time to time. Coordinate with licensing team for issuance of the same

- Receive finished packs along with COA to enable filing of dossier

- Arrangement for registration/reregistration samples

- Support preparation and approval of new artwork. Archive approved copies

- Prepare Regulatory requirements map of biologicals/biosimilars for Emerging market countries and updating the same

- Prepare and file applications for test licenses/Test license NOC/Export NOC/product permissions/marketing authorization for drug substance and product

- Archive all submissions

- % adherence to

Plant related activities and RA support

- Review and approve change controls/ deviations/OOS for drugs and products (with thorough assessment of impact on product quality and regulatory submission)

- Review quality agreements with regulatory perspective

- Participate in plant meeting and keep self updated with ongoing product development activities/strategies

- Review SMF, VMP, SOPs, study reports, etc.

- Preparing for and participating in GMP/marketing authorization audits of facility and for due-diligence/client visits

- Update cross functional teams regarding regulatory/quality guidance/other relevant information

- Coordinate with the plant and R&D for various documents required for review and RA archival

Phone: 8104875887