Associate Director Regulatory Affairs Biosimilars

4 weeks ago

Mumbai, India Abbott Full time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Abbott Established Pharmaceutical Division (EPD) is looking for a

Associate Director Regulatory Affairs Biosimilars

for its global Pharma Division Headquarter based in Allschwil- Basel.

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:

Bachelor's 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

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application as pdf .

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