Regulatory Affairs Manager

Astellas Pharma India i s looking for a Regulatory Affairs (RA) Manager , based in Mumbai, India. Purpose and Scope:

• Planning, preparation and submission for Market Authorization, Registration of product, new indication, and maintenance of registration and its compliances.
• Interaction and coordination with DCGI(CDSCO) and SFDA and concerned regulatory bodies for necessary regulatory approval and license
• Back-up support to Pharmacovigilance

• Supports planning for Market authorization of new products in India
• Preparation and compilation of Regulatory dossier for Market authorization
• Preparation and submission of dossier for registration based on strategies of new product development plans.
• Assessment of Post Approval changes/variations and submission for necessary approval from Regulatory Authority
• Coordination with Global RA team for assessing & implementing of new regulation and compliances and supporting RA projects
• Maintenance of Registrations and licenses with timely planning and submission of renewal for continuity of business
• Preparation and review of Artwork, Product leaflet, API and coordinate with Labeling and packaging team for timely execution and product launch
• Building association liaising with Indian health authorities (CDSCO), State FDA, CDTL, IPC etc.
• Close coordination with internal stake holders(Medical Affairs, Marketing, Supply chain, Commercial & sales) to provide regulatory consultation and support in business
• Manage implementation, utilization and compliance to RA systems (Veeva, EAGLE, GRACE, CCTA, BLUE etc.).
• PromoMat review for regulatory and Code of compliances and consultation to Marketing team.
• Back-up support to Pharmacovigilance

• Monitor the PV mailbox, 24/7 PV telephone, and other sources of product safety information (e.g., reported as part of Product Quality Complaints and Medical Information Enquiries)
• Process safety information (Adverse Events) received from all sources by the Affiliate, in compliance with required timelines (reporting timelines), quality guidelines, and standards. Processing safety information includes the collection, translation, and forwarding to designated Regional Global PV Headquarters. If applicable: Timely ICRS submissions to the Competent Authority
• Use PV Case Tracking System, PV Register/LSIT/LSMV to capture Product Safety Information accurately.
• Conduct local literature searches for Product Safety Information according to the relevant procedures, if applicable.
• Conduct and document follow-up of Product Safety Information as required per relevant procedures.

• Provide input for the PSMF regarding the affiliate communication to PV Regional Head Quarters
• Be aware of outsourced PV activities
• Ensure filing, storage, and archiving of PV documentation in accordance with PV regulations and with Astellas policies and procedures
• Request to have access to, and be aware of, the affiliate business continuity plan (for example, system failure and other disasters) in relation to PV activities.
• Be aware of all local studies and projects, including digital media and Astellas sponsored websites that impact PV.
• Ensure that communications from competent local authorities are forwarded to the Regional PV office - and work with the PV Regional HQ Office and Regulatory Affairs - to ensure appropriate response are presented to competent local authorities, where applicable.

• Working knowledge on regulatory environment of Indian pharmaceutical industry
• Good knowledge of Drugs and Cosmetics Act & Rules, India
• Good knowledge about regulations on new drug registration and clinical trial.
• Good knowledge about Indian Regulatory guidelines and procedure
• Good English for communicate with Global Colleagues
• University graduate and master majored in life science, medicine, pharmaceuticals.

• Working experience in pharmaceutical industry for minimum of 5-8 years
• Experience in regulatory affairs specially in registration of new drugs at least 5 years
• Experience in new product development.
• Experience in preparation of dossier for new chemical entities and new formulations.
• Engaged in industry activities and experience in liaising with Indian Health Authority

• This position is based in Mumbai and will requireon-site work. Maximum 1 day a week, work from home might be allowed.