Career Associate Manager in Regulatory Affairs @Johnson & Johnson
Post : Associate Manager, Regulatory Affairs
Purpose of the Position
• To act as a strategic business partner to support Selfcare (Drug) portfolio for India RA.
• Contribute to develop innovative RA strategies for New Products, LCM and assessment of competitive claims development in selfcare (drugs)
• Proactively identify potential impact of upcoming regulations through timely regulatory intelligence with problem solving approach
• Up to date on current changes in environment of regulations in various markets on OTC policy, and support Leadership appropriately for advocacy on OTC regulation in India
• Contribute in India-Selfcare Regulatory strategy development and ensure timely execution on all deliverables in agile manner including dossier submissions, artwork & claims review, with accuracy and end to end mindset, etc.
• Collaborate with business partners to provide regulatory strategies and support for robustness of regulatory compliance in everything we do.
• Ensure compliance and be audit Ready for Internal & External audits.
• Ensuring timely responding to regulatory queries including CDSCO, State Drug Control offices, ASCI, etc
• Ensure getting adequately trained and developed. Ensure that an active coaching and development culture operates in the regulatory team with cross skilling and information / knowledge sharing
1. Masters in Pharmacy / Bachelors in Pharmacy with PG Diploma in Regulatory Affairs
2. Experience: 8-10 Years in Indian drugs Regulatory domain. Experience of handling cosmetics and food regulatory work would be considered as value addition.
3. Adequate regulatory and technical knowledge in Selfcare, proficiency in law interpretation skills, effective interpersonal skills, and with high adaptability, in a complex environment with strong work ethics
Experience : 8-10 years
Qualification : B.Pharm, M.Pharm
Location : Greater Mumbai
Functional Area : Regulatory Affairs
Last date : 30th August, 2020
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube