Assistant Manager -Regulatory Affairs

Overview

Assistant Manager, Regulatory Affairs role in Abbott's EPD Established Pharma division, supporting global labeling and regulatory submissions, working under manager oversight and supervision.

What you'll do

• Develop and maintain EPD Company Core Data Sheets (CCDS) and Company Core Patient Information (Master Package Leaflet) based on scientific knowledge, labeling guidelines and requirements within the Abbott EPD Labeling Process.
• Ensure CCDS information is based on Subject Matter Expert (SME) contribution.
• Organize and participate in Labeling Sub-Team (LST) meetings and ensure appropriate actions are followed through.
• Work with Product Leads, SMEs and cross-functional teams to ensure documentation supporting label changes (clinical overviews, Module 5 documents, literature references, etc.) is available to complete labeling projects.
• Independently complete assigned labeling activities with oversight.
• Assess and approve change requests for labeling documents.
• Participate and contribute to labeling decisions within cross-functional teams.
• Supervise labeling compliance of local labeling documents and reconcile deviations with company labeling documents (e.g. CCDS, corresponding patient information).
• Review and evaluate new labeling guidelines/policy (High surveillance countries) and determine implications for company labeling documents and labeling of therapeutic area products.
• Work with Product Leads and SMEs to develop strategic labeling responses within the cross-functional team at the appropriate time.
• Support GRDS Leads, or act as GRDS Lead, for assigned products for all non-CMC documents required by affiliates for regulatory submissions in a timely manner.
• Maintain accurate files of labeling change history and associated documents using available company electronic systems.
• Review and approve promotional materials with respect to CCDS and globally applicable guidance, ensuring they are accurate and compliant with internal codes of conduct and established regulations.
• Provide labeling support to affiliates, including supporting renewals, geo expansions or any license maintenance activity.
• Educate and guide stakeholders on labeling procedure as required, with manager's oversight.
• Work with RA Ops to prepare Module 2, Module 4 and Module 5 and have them ready for affiliate publication.
• Coordinate RA information for periodic reports (RMP, PSURs, ACOs for renewals).
• Support renewals with clinical and pre-clinical documentation (EU and EM).
• Provide relevant documents for variations to EU and EM affiliates.

What you'll need

• Bachelor's degree in Pharmacy or a life science related subject with appropriate qualification.
• Ideally 5-7 years of work experience in the pharmaceutical industry.
• Previous experience in Regulatory Affairs, Global Labeling, PV, Medicines Development, Quality or related area(s).
• Excellent command of spoken and written English (mandatory).
• Strong interpersonal skills to work with global teams (critical).
• Attentive to detail.
• Advanced word processing knowledge and experience with Microsoft Office products (Word, Excel and PowerPoint).
• Adaptability, initiative, innovation, integrity and teamwork as described in the key competencies.

Nice to have

• Diploma in Regulatory Affairs.
• Knowledge and hands-on experience with labeling texts for both health professionals and patients.

Details

• Location: India, Mumbai (BKC Building).
• Work shift: Standard.
• Travel: up to 15% may be required.
• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day).