Job title: Manager Regulatory Affairs
Company: Abbott
Job description: JOB DESCRIPTION:
– 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.
With Manager Oversight and Supervision:
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.
Travel:
Up to 25% may be required
JOB SPECIFICATIONS:
Skill, Education, Experience Minimum Education:
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)
The salary for this role is between: N/A
JOB FAMILY: Regulatory Operations
DIVISION: EPD Established Pharma
LOCATION: India
Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Yes, 20 % of the Time
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Expected salary:
Location: Mumbai, Maharashtra
Job date: Tue, 08 Nov 2022 23:20:57 GMT
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