Manager Regulatory Affairs External Manufacturing

Main responsibilities:

Indicate here the main job responsibilities with bullets points, avoiding Sanofi corporate jargon, acronyms, and gender-coded words (you can check if your language is neutral on this site )

Product Dossier Management for Export Products:

• Writing of renewal dossiers of products manufactured in Indian CMO s and exported to Russia, Ukraine, other CIS countries, Sri Lanka, Nepal, Latin American countries and other countries (if any addition) etc.
• Writing and review of new product dossiers/ renewal dossiers for products manufactured at CMO s based in South Korea, Thailand and Philippines for export markets.
• Maintenance of the entire renewal dossier and new product dossiers for Indian CMO s and overseas CMO s.
• Preparation and submission of post approval variations and send proper communication for implementation of the change.
• Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the required documentations.
• Consolidate the regulatory strategy with the affiliate or the Global RA to submit the site change
• Updation of eTOC and dispatches dossiers through Veeva Vault.
• Maintenance and distribution of Normative document to the responsible quality manager.
• Implementation and follow GRA processes for all export product dossier management.
• Life cycle management for all the products managed by EM India.

Regulatory status Management of Local products:

• Preparation of applications for procuring and renewal of Mfg. License/ WHO GMP. Certificates/COPP/Import license/ Sch. M GMP Certificates at External manufacturing sites
• Preparation of applications for Procuring Regulatory certificates for tender business (for Ext. manufacturing sites).
• Writing dossiers and co-ordination with CMO s for dossier submission and management of domestic markets of Thailand and Korea.
• Maintaining Regulatory status at External Manufacturing sites - preparation of applications to procure new manufacturing licenses/ additional products/ surrender of license which are no more required.
• Sending Finished Product Samples/ working standards to Reg. Authorities when asked for Follow-up and replies to complaints received.

Artwork Review:

• Review and Approval of packing material artworks as per the Regulatory requirements.
• Evaluate and anticipate the changes in artworks due to new regulation or guidance.

Documentation:

• Review of all the change controls initiated by QMS team w.r.t. Regulatory impact.
• Initiation and evaluation of CCRF for global and regional products.
• Co-ordinate participate in change control committee.
• To upload APQR in PQR workspace.
• Review of any other documents having Regulatory Impact.
• To maintain the regulatory database.
• Prepare SOPs applicable to the department and maintain relevant records

Co-ordination with cross functional team for documentations required for submission of dossier or other applications to health authorities. Actively participate in the meeting organized by stake holders.

Review of Pharmacopoeia changes impacting to EM India product portfolio and make action plan for Implementation of the change.

About you

List here ideally the must-haves criteria to be successful on the role. Don t forget: the less criteria you will request, the more diverse candidates you will get in the pool.

• Experience: (8-12 years of experience in Regulatory Affairs, Quality Assurance)
• Soft skills: Transversal skills, Stakeholders management, Effective communication with external partners and ability to work independently.

• Technical skills: Regulatory Affairs, Quality Assurance, Effective Analysing skills, Strong cross-functional collaboration, teamwork, and stakeholder management.
• Managerial courage - ability to make difficult decision and implement successfully

• Education: (B.Pharm/ M.Pharm/ MSc in lifesciences)
• Languages: English, Hindi

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