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
Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives. To contribute in various regulatory/scientific and technical aspects including partnering in external engagement related activities being part of India Regulatory Affairs function to meet the organization's expectations for productivity, quality, and goal accomplishment.
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 items
5. 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.
Candidate Profile
1. Technical Qualication: Master’s in pharmacy / Bachelor in Pharmacy with PG Diploma in Reg Affairs
2. Skills: Adequate regulatory knowledge & communication skills, positive and learning attitude
Experience: 8 to 10 Years in Regulatory Affairs
Additional Information
Experience : 8-10 Years
Qualification : B.Pharm, M.Pharm
Location : Maharashtra-Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th July, 2019
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