Regulatory Affairs Manager Job at Abbott India Limited

Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, diversified 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 : Regulatory Affairs Manager

Job Description
• Assists the GRDS Lead as the primary EPD RA interface within assigned Global Development Project Teams providing global regulatory strategic advice for assigned product(s), under supervision maintaining a relationship as a strategic partner
• Provides non-CMC global regulatory support under supervision for assigned product(s) and L&A activities, as necessary. Product specific regulatory contact in Product Safety Teams (PST), Labeling Sub-teams (LST), project teams and other key supporting non-CMC functions in PV, Medical/Clinical
• Assists the GRDS lead as primary interface within assigned Project Teams, to develop and manage global regulatory strategy with supervision ensuring appropriate input is received from functional sub-team members.
• Assists in building, maintaining and executing of non-CMC global regulatory strategies (including labeling) for assigned product(s) with input from RA sub-team members
• Provide regulatory input into the content of non-CMC parts of dossiers such as Labeling, Clinical/non-Clinical sections, RMPs, PSURs; etc, to support new filings, variations, renewals;
• Recommend & contribute to continuous process/program improvements within GRDS
• Ensures regular communication and feedback from GRDS Director

Core Job Responsibilities
• Provide strategic regulatory advice for assigned Development Programs to I&D/ Commercial counterparts under supervision.
• Develop and manage global regulatory strategies ensuring appropriate input is received from functional sub-team members under supervision
• Attendance at project teams (Development Project Teams, Product Safety Teams, etc.) and Regulatory sub-team meetings, representing EPD Global RA as appropriate with supervision.
• Assists in preparing regulatory submissions and developing strategy with supervision for response to regulatory agency queries. Responsible for ensuring accuracy and quality of non-CMC documentation.
• Monitoring actual vs. planned activities/timelines, start to identify/recommend improvements to correct or accelerate project progression
• Recommend & contribute to continuous process/program improvements within GRDS
• Provides regulatory input into the content of non-CMC parts of dossiers such as Labeling, Clinical/non-Clinical sections, RMPs, PSURs; etc, to support new filings, variations, renewals
• Provides strategic input into core CCDS and label questions.

Candidate Profile
• Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• Excellent oral and written communication and interpersonal skills, excellent English mandatory.
• Attentive to detail. 2-3 years of Regulatory experience preferred; related duration of experience in Quality, R&D, Scientific Affairs is considered

Additional Information
Qualification : B.Sc. or B.Pharma
Location : Mumbai
Experience : 2-3 years
Functional Area : Regulatory Affairs
End Date : 10th July, 2021