Job title: Assistant Manager – Regulatory Affairs
Company: Abbott
Job description: Core Job Responsibilities: – Provide strategic input into the development of regulatory submissions and timelines for assigned products/projects, seeking guidance where appropriate.u00A0 – Provide input into international regulatory submission plans
Core Job Responsibilities: – Provide strategic input into the development of regulatory submissions and timelines for assigned products/projects, seeking guidance where appropriate.u00A0 – 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.u00A0 – Assist with the preparation and review of technical regulatory documentation for agency submission.u00A0 – 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 datau00A0 – 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: u00A0 Up to 25% may be required u00A0u00A0 u00A0 JOB SPECIFICATIONS:u00A0 Skill, Education, Experienceu00A0u00A0 u00A0Minimum Education: Bacheloru2019s Degree in pharmacy, biology, chemistry, pharmacology or related subject. u00A0Diploma 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)
Expected salary:
Location: Mumbai, Maharashtra
Job date: Wed, 19 Oct 2022 22:17:54 GMT
Apply for the job now!