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268 Abbott Jobs
Associate Director Regulatory Affairs Biosimilars
10-15 years
Mumbai
1 vacancy
Associate Director Regulatory Affairs Biosimilars
Abbott
posted 17d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
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:
- 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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36%
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8%
7%
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What people at Abbott are saying
Associate Director Regulatory Affairs salary at Abbott
reported by
3
employees
with 20-26
years exp.
₹42
L/yr - ₹51
L/yr
27%
more
than the average Associate Director Regulatory Affairs Salary in India
View more details
What Abbott employees are saying about work life
based on 3k employees
Flexible timing
Monday to Saturday
Within city
Day Shift
Abbott Benefits
Submitted by Company
Healthcare Incentive program Vacation & Holidays Life insurance
Submitted by Employees
Health Insurance 
Job Training 
Soft Skill Training 
Free Transport 
Work From Home 
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Abbott Mumbai Office Locations
Mumbai Office
Headquarter
271, Business Park, Model Industrial Colony, Off Aarey Road, Goregaon (E)
Mumbai
Maharashtra 400063
Maharashtra 400063
Mumbai Office
Abbott Laboratories (India) Limited, Padmaja Apartment-a, Yari Road, Versova, Versova
Mumbai
Maharashtra 400061
Maharashtra 400061
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