• Associate / Assistant Manager Regulatory Affairs Jobs in Mumbai City - 23855798

  • Abbott Healthcare
  • Mumbai City

Job Description:

JOB DESCRIPTION
An opportunity to work within the CMC Regulatory function of an established fast-moving and ambitious multinational pharmaceutical company supporting a broad range of products including medicines, medical devices and foods supplements across multiple therapeutic areas

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

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


Candidates should also demonstrate the following attributes


  • 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


Ability to work autonomously where necessary and to self-manage time and workload

JOB FAMILYRegulatory Operations

DIVISIONEPD Established Pharma

LOCATIONIndia > Mumbai BKC Building

ADDITIONAL LOCATIONS

WORK SHIFTStandard

TRAVELYes, 15 % of the Time

MEDICAL SURVEILLANCENot Applicable

SIGNIFICANT WORK ACTIVITIESContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Profile Summary:

Employment Type : Full Time
Industry : Medical / Healthcare
Salary : Not Disclosed
Deadline : 19th Apr 2020

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