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301 Abbott Jobs
Associate Director Regulatory Affairs Biosimilars
10-15 years
Mumbai
1 vacancy
Associate Director Regulatory Affairs Biosimilars
Abbott
posted 2mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Prepare, execute, and implement the global regulatory strategy for new biosimilar / biotech product introduction and life cycle maintenance (CMC and non-CMC)
- Lead biosimilar/biotech projects, compile, and prepare high quality regulatory documentation for complex global regulatory submission worldwide
- Lead x-fct strategy and preparation for scientific advice for assigned biosimilars / biotech products incl preparation of briefing book and coordination with affiliate and SMEs
- Leads and coordinates regulatory due diligence activities for assigned biosimilar/ biotech projects.
- Be the lead member from global regulatory on behalf of regional and national regulatory function in project team and represent global regulatory affairs function
- Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout development and product life cycle according to the plan.
- Ensure and lead regulatory compliance for assigned biosimilar / biotech products across all EPD markets
- Review and assess impact of regulation changes, new regulation and competitive intelligence and translate it into impact and mitigation strategies / opportunities for EPD biosimilar / biotech products decisions for Abbott biosimilar products.
- Generate and communicate biosimilar intelligence to bring awareness and refine actively identify and lead strategic external engagement to shape the external RA landscape for biosimilars / biotech products in EPD markets
- Partner with regulatory team at global and affiliate level to build, align, communicate, and execute regulatory strategies, according to timelines and priorities communicate.
- Identify process needs to meet internal & external challenges
- Escalate regulatory issues, progress, and metrics to functional head
- Bachelors Degree in pharmacy, biology, chemistry, pharmacology, or related subject
- 10+ years experience in Regulatory Affairs biosimilar/Biotech
- Regulatory experience with biosimilar development & product filings
- Ability to influence, understand and communicate scientific CMC and non-CMC information
- Team skills, especially in working with internal and external partners and performing due diligence
- Demonstrated success in leading/executing Regulatory across Emerging markets
Employment Type: Full Time, Permanent
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Abbott Mumbai Office Locations
Maharashtra 400063
Maharashtra 400061
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