Regulatory Affairs Specialist

2 weeks ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000
Job Description:

We are seeking a highly skilled and dedicated individual to join our team as a Regulatory Affairs Specialist. The successful candidate will be responsible for the delivery of marketing applications, pre-approval investigations, and lifecycle maintenance submissions to agreed timelines and in compliance with regulatory authority regulations and guidelines.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure timely submission of marketing applications.
  • Coordinate with cross-functional teams to gather required information and documentation.
  • Review and revise submission documents to ensure accuracy and completeness.
  • Liaise with regulatory agencies to resolve issues and address concerns.
  • Provide guidance and support to project teams and client groups on submission-related processes and content requirements.
Required Skills and Qualifications:
  • Bachelor's degree in a relevant field such as life sciences, pharmacy, or law.
  • Minimum 3 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
  • Strong knowledge of regulatory frameworks, guidelines, and regulations.
  • Excellent communication, interpersonal, and project management skills.
  • Ability to work independently and as part of a team.
Benefits:

We offer a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.

About Us:

We are a global biopharma company dedicated to improving human health through scientific innovation. We invest in research and development to create new treatments and therapies for patients worldwide.

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