Regulatory Affairs Job Opportunity at Biological E Limited!
Role/Designation: Senior Executive/ Executive – CTD Specialist – ROW Market
- Qualification: M. Pharmacy/ M. Sc
- Desired Experience : 5- 9 years
- Job Location : Genome Valley, Shamirpet, Hyderabad
- Preferred Industry : Vaccines / Biotech
Job Responsibilities:
Responsible for Regulatory submission to ROW
Experienced in handling, management and expansion of product portfolios, markets/ territories.
Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC.
Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited)
Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc.
Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc.
Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO.
Application for Post Approval Change(s), Variations and Comparability packages
Author, review and submission of responses to India, EM, WHO and Regulated markets..
Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc..
Handling the Health Agency audits for India, EM, Regulated and WHO inspections
Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External).
Review of Artworks (Labels and Package Insert) and Pack Profiles.
Any other regulatory support required by the organization per submission need.
Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for “Regulatory Affairs”
