Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds. Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.
Post : Manager, Regulatory Affairs
Job Description
- Responsible for planning and maintaining work systems, procedures, and policies that enable and encourage the optimum performance of the Regulatory Affairs team members by setting and managing work priorities and timely guidance.
- Manage the timely and professional delivery of regulatory activities for relevant products pro-actively to support the business goals including management of finalization of dossiers & related activities for Domestic/ Import/ Export products registration/renewal for drug/ cosmetics / food/ other commodities items
- Collaborates with Leadership team in activities related to External Engagement E.g. Interaction with Regulatory Authorities, Industry /Trade Associations, Industry colleagues, etc. to develop and maintain relationships with key personnel of various government departments.
- Represent organization while responding to regulatory agencies queries and other correspondence after engaging and interacting with regulatory authority like State FDAs, CDSCO, FSSAI, Legal Metrology, etc.
- Directs and coordinates activities for reviews & approve claims, promotional materials and artworks, as applicable
- Provide guidance to RA team members to have departmental audit readiness (internal/external) all the time and confirming the completion of audit action plan, if any as per timeline.
- Partnering with Business Stakeholders to provides active regulatory support for robustness of regulatory compliance
- Maintain high-level departmental profile through regular communication with local business including representation of the Regulatory Affairs team at various internal forums.
- By means of performance review system, ensure self and other team members are adequately trained, informed and developed. Ensure that an active coaching and development culture operates in the regulatory group with cross skilling and information / knowledge sharing.
Candidate Profile
1) Technical Qualification: Master in Pharmacy
2) Skills: Adequate regulatory knowledge & communication skills, positive and learning attitude
Additional Information:
Location: Maharashtra-Greater Mumbai
Education: M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
Job Code: 1805618921W
End Date: 09th February, 2018
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