Manager Regulatory Affairs | Abbott | Mumbai

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 teamwork
– Represent Regulatory Affairs at relevant meetings and present the agreed RA CMC position
– Build and maintain relationships within the CMC group and one-on-one relationships with relevant counterparts such as Global and Regional Product Leads, MS&T, Quality, and 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.

Job Specifications:

Skill, Education, Experience

Minimum Education:

Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or a related subject.  A 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 of 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 PowerPoint)