Pharma Manager-Regulatory Affairs Post @ Johnson & Johnson
Johnson & Johnson is a leading company with numerous job openings for Pharma candidates. J&J is currently hiring for Associate District manager job opening. Candidates with a masters degree in Pharma may apply for this job post via online mode. Check out all the details on the same below:
Job Title: Manager-Regulatory Affairs
No.of posts: 01
Eligibility: Master’s in pharmacy / Bachelor in Pharmacy with PG Diploma in Reg Affairs
Skills: Adequate regulatory knowledge & communication skills, positive and learning attitude
Experience: 8 to 10 Years in Regulatory Affairs
Key Responsibilities:
1. 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
2. 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.
3.. 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.
4. Manage the timely and professional delivery of regulatory
activities for relevant products pro-actively to support the business goals including management of rationalization dossiers & related activities for Domestic/ Import/ Export products registration/renewal for drug/ cosmetics / food/ other commodities items5. Directs and coordinates activities for reviews & approve claims, promotional materials and artworks, as applicable
6. Provide guidance to RA team members to have departmental audit readiness (internal/external) all the time and conforming the completion of audit action plan, if any as per timeline.
7. Partnering with Business Stakeholders to provides active regulatory support for robustness of regulatory compliance
8. Maintain high-level departmental role through regular communication with local business including representation of the Regulatory Affairs team at various internal forums.
9. 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.
Apply Online
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