GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns
Job Title: Assistant Manager – Regulatory Affairs
Location: Worli Mumbai, India
Eligbility Criteria:
Preferably Degree in Pharmacy or Biomedical discipline.
Experience Requirements/skills
- Professional experience with 3-5 years of relevant regulatory experience
- Up-to-date regulatory knowledge required to do the job as described above, SUGAM portal handling experience
- Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives
- Project management skills
- Good communication skills – both oral and written
- Demonstrate strong teamwork ability and able to execute role independently
- Task oriented with learning attitude
Job Purpose-
Assist the Regulatory Affairs Manager in fulfilling regulatory responsibilities for activities related to registration of new drugs and lifecycle management of existing products for Pharma, Biopharm, Cosmetics and Vaccines for India.
Key Responsibilities-
1. Compilation and submission of Quality Regulatory Dossiers for following categories of applications for Pharma, Biopharm, Cosmetics and Vaccines products:
• New Products (NDA/Marketing Authorization) and Line Extensions/Additional Indications
• Clinical Trial Applications (local/global studies)
• Registration of Manufacturing Sites & Products, Import Licenses
• Maintenance Applications/Life cycle management:
➢ Renewals of Registration Certificates/Import Licenses
➢ Technical Variations (CMC)
➢ Clinical Trial Protocol Amendments/ Study updates and other compliance activities
➢ Post Approval Commitments (PACs)
➢ PSURs
➢ RMPs
• Prescribing Information updates and its submission to CDSCO as per TSC timelines
2. Liaise with GRA Pharma / Vaccines for Regulatory requirements, feedback, Vault updates, etc.
3. Ensure regulatory compliance to requirements of Drugs and Cosmetics Act for GSK products approved by DCGI.
4. Systems and Processes:
• Track and maintain the product lifecycle on local XL database for the projects assigned
• Track submission status & follow-up on local XL database on Regulatory Vault
• Ensure Archival of submissions, correspondences and any miscellaneous
communications with the authority in Regulatory Vault
5. Support implementation of QMS compliant process for regulatory affairs function for the relevant identified activities.
6. Identification and forwarding all relevant Quality and Regulatory Intelligence (QRI) received to EVP Regulatory Affairs/designee for assessment, communication and acting upon relevant intelligence which may present a potential risk or opportunity to GSK, require GSK input to influence new requirements or require GSK to make changes to ways of working
7. Ensure compliance to KPIs by periodic monitoring of database systems such as Regulatory Vault
8. Timely completion of RA training, modules and SOPs
Apply Online
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