Business Analyst - Regulatory Affairs

Recruiter
Genpact
Location
Mumbai, Maharashtra, India
Salary
Competitive salary
Posted
28 Nov 2020
Closes
30 Nov 2020
Ref
CPG018243
Job role
Business analyst, CFO
With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world's biggest brands-and we have fun doing it. Now, we're calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.

Are you the one we are looking for?

We are inviting applications for the role of Business Analyst, Regulatory affairs!

In this role, you will be responsible to work on deadlines, in a fairly high pressure business environment while being a good team member. You should have the ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.

Should be open to work in any shift as per the business requirement.
Responsibilities
The Role demands for a highly qualified professional who should have Labelling experience under regulatory affairs domain. BA will be responsible for all the activities related to -
  • Collaborate closely with key interfaces on project requirements to ensure timelines are mutually understood.
  • Drafting responses to MAH for Health Authority queries.
  • Identify discrepancies/issues in local implementation of corporate labels.
  • Lead team for timely results.
  • Supervise reference labels (from up to three countries) for updates and ability to connect with concerned affiliates directly using Sanofi communication/collaboration tools.
  • Maintaining updates related to labeling guidelines and regulations as they pertain to the development/maintenance of CCDS, US, EU and ROW labeling.
  • Ability to identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
  • Ability to construct a Company Response (MAH response) for health authority questions
Minimum Qualifications
  • Bachelor's degree in pharma / Science
  • Strong financial analytical skills and problem solving skills.
  • Effective communicate in writing and verbally to senior management.
  • Experience in balancing customer facing role and work assessments.
  • Self-starter and have analytical, prioritisation skills
  • Ability to balance customer governance meetings
Preferred qualifications
  • Able to further robust working relationships with the team, peers and clients, scheduling flexibility required
  • Overall candidate should have decision-making, macro-level research and analytics approach and good in numbers.
  • Good people and customer handling skills.
  • Effective communication and interpersonal skill.

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