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Associate Director Regulatory Affairs Biosimilars
10-14 years
Mumbai Suburban, Colombia, Switzerland
1 vacancy
Associate Director Regulatory Affairs Biosimilars
Abbott Diabetes Care
posted 18d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Primary Job Function:
- 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
Core Job Responsibilities:
- 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
Minimum Education:
- Bachelors Degree in pharmacy, biology, chemistry, pharmacology, or related subject
Minimum Experience/Training Required:
- 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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Flexible timing
Monday to Saturday
Within city
Day Shift
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Associate Director Regulatory Affairs Biosimilars
10-14 Yrs
Mumbai Suburban, Colombia, Switzerland
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