Regulatory Affairs – Biologics
- Compensation
- Not disclosed
- Location
- Ahmedabad, Gujarat, India
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Legal
- Posted
Skills
Full description
- Preparation and
submission of dossiers for EMB, country-specific dossiers, CTD, ACTDand
eCTD.
- Responsible for assigned
products - Master dossier upgradation.
- Query response
preparation and submission in emerging market
- Co-ordination with BD
team, country manager and international regulatory agencies
forregistration of products for emerging market
- Post-approval change
application for the approved products in emerging market forcommercial
support
- Supporting global
filing, and preparation of briefing packages.
- Supporting in routine
activities like artwork management, incoming document review, Gapanalysis.
Business development support etc.
- Supporting Domestic
activities like preparation, review and submission to CDSCO/ FDCA
- Post-approval change
application for the approved products
- Regulatory knowledge
sharing: Read and share new regulatory guidelines, trends, expectations
and compliance documents. Do impact analysis with internal product
development strategies. Acquire knowledge of the activities in new
territories and keep upto date with current requirements.
- Interact, develop and
maintain relationships with regulatory / drug control authorities
/government agencies and other external regulatory experts.
- Coordination with Mfg.
sites for documents arrangements, samples arrangement for EMB submissions.
**Key
competencies expected:**
- Good understanding of
Biotech process and Analytical
- Supported Regulatory
Affairs for dossier preparation, review and query response
- Overall understanding of
product development