Work as Associate / Assistant Manager - Regulatory Affairs at Abbott India Limited

Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified 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 : Associate / Assistant Manager - Regulatory Affairs

Job Description
The role involves, but is not limited to, the following activities:
• Managing multiple activities according to agreed timelines and deliverables
• Acting as the CMC subject matter expert in cross-functional project teams
• Evaluating, interpreting, simplifying and communicating complex situations and data
• Evaluating and interpreting legislation and its impact on the business
• Generating innovative and robust regulatory strategies
• Identifying and evaluating risks and providing mitigation plans
• Providing mentoring support and guidance to more junior colleagues
• Writing and compiling high-quality right-first-time submission-ready CMC documentation
• Liaising with colleagues across multiple time zones

Candidate Profile
The right candidate will have at least 8+ years of experience within Regulatory Affairs and will be able to demonstrate strong technical Chemistry Manufacturing and Controls skills. A pharmaceutical development or production background is desirable. The position encompasses full life-cycle management activities; therefore, experience of supporting pre-approval product development and post-approval licence maintenance activities is essential. The company operates in multiple geographies and so experience in at least two of the following regions is a pre-requisite: Middle East and Africa; Russia and CIS; South East Asia and Greater China; Latin America.
• Measured decision making and risk taking
• Excellent written and verbal communication skills
• Strategic, creative and lateral thinking and problem solving
• Enterprise thinking (seeing the big picture)
• Ability to build and maintain relationships and credibility with peers and partners
• Willingness to develop self and others
• Attention to detail
• An understanding and awareness of and respect for cultural differences

Additional Information
Qualification : B.Sc, B.Pharm
Location : Mumbai, Maharashtra, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
JOB ID : 30925369
End Date : 25th October, 2019