Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post : Assistant Manager Regulatory Affairs
Job Responsibilities:
- Provide strategic input into the development of regulatory submissions and timelines for assigned products/projects, seeking guidance where appropriate.
- Provide input into international regulatory submission plans as appropriate.
- Attend and actively participate in regulatory sub-team meetings that include representatives from different international locations.
- Monitor actual vs. planned activities and timelines and identify issues impacting project progression.
- Assist with the preparation and review of technical regulatory documentation for agency submission.
- Ensure the accuracy and quality of documentation included in regulatory submissions.
1. Product registrations /Submissions
- Prepare CMC registration packages to support new registrations, post approval changes, and renewals
- Identify and collect required data
- Seek expert advice and technical support to complete packages
- Prepare responses to deficiency letters
2. Relationships & Cross Functional team work
- Represent Regulatory Affairs at relevant meetings and present agreed RA CMC position
- Build and maintain relationships within CMC group and one-on-one relationships with relevant counterparts such as Global and Regional Product Leads, MS&T, Qualityand drug product development
- Monitor actual vs. planned activities and timelines
- Identify and communicate issues impacting project progression
3. Compliance across Life-Cycle
- Assess and approve manufacturing change requests and update files accordingly (may not be applicable to all staff)
- Maintain awareness of legislation and current developments within specific area of business
- Work to assure products remain in compliance
4. Strategy
With manager oversight, for complex projects or independently for routine projects:-
- Develop regulatory product CMC strategies
- Identify risks and elevate them along with possible remediation
5. Process Improvement
- Independently identify opportunities and suggest improvements for resolution
- With oversight, lead the development of position papers & work aids etc.
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Candidate Profile
Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology or related subject. Diploma in Regulatory Affairs is preferred.
Minimum Experience / Training Required:
- Excellent oral and written technical skills
- Excellent command over spoken and written English is mandatory
- Strong interpersonal skills to work effectively with global teams is critical
- Attentive to detail
- Ideally, 5-7 years work experience in the pharmaceutical industry such as R&D, Quality, Product development
- Preferred experience in Global Regulatory filings, submission of registration dossiers and post-approval variations
- Advanced word processing knowledge and experience with Microsoft Office products (Word, Excel and Power Point)
Additional Information:
Exp: 5-7 yrs
Location: Mumbai
Education: B.Sc; B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
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