Regulatory Affairs Professional

4 days ago

Gurgaon, Haryana, India beBeeRegulatory Full time US$ 80,000 - US$ 1,20,000
Job Description

As a Regulatory Affairs Manager, you will play a pivotal role in ensuring the success of new product registration, line extensions, and new indications for the marketing affiliate. Your primary responsibilities will include:

  • Executing the Regulatory Plan to ensure compliance with local regulations and quality system requirements.
  • Managing relationships with cross-functional teams to achieve Affiliate regulatory objectives.
  • Facilitating interactions with regulatory bodies on a regular basis.

Key responsibilities include:

  • Implementing the Regulatory Plan in alignment with affiliate business plans and regulatory requirements.
  • Ensuring submission and approval of high-quality regulatory applications within planned timelines.
  • Maintaining or supporting maintenance of clear metrics for Regulatory deliverables.

Additionally, you will:

  • Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team and New Product Planning discussions.
  • Anticipate potential regulatory constraints and deliver regulatory outcomes to support the affiliate launch plans.
  • Communicate changes to management and cross-functional experts as appropriate and implement locally.
Required Skills and Qualifications
  • Bachelor's degree or equivalent in a relevant scientific subject.
  • At least one year industry-related experience in regulatory affairs and experience of dealing with external regulatory agencies, healthcare systems, and marketing needs.
  • Team working skills with special focus on results.
  • Ability to adapt to challenging situations.
  • Demonstrated good computer/IT skills.
  • Good knowledge of written and spoken English.
Benefits

This role offers a unique opportunity to develop your expertise in regulatory affairs and make a meaningful contribution to the success of the marketing affiliate.

Others
  • Analytical, problem-solving, and negotiation skills.
  • Good communication skills.
  • Project management skills.
  • Strong planning and priority setting.
  • Good capability to establish positive networking both internally and externally.
  • Strong knowledge of quality systems.

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