Chief Regulatory Compliance Officer

5 days ago

Daman, Daman and Diu, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

We are seeking a seasoned Regulatory Affairs Manager to spearhead our global regulatory strategies.

Job Description

The successful candidate will be responsible for ensuring timely product approvals and market access across multiple health authorities, including the FDA, EMA, MHRA, TGA, Health Canada, and others.

Key Responsibilities
  • Develop and implement global regulatory strategies to ensure business continuity and Day 1 launches in key markets.
  • Evaluate pre-PIFs and provide regulatory submission requirements for US & EU, with extended submissions for Australia, Canada, and other regions.
  • Collaborate with R&D, Quality, Manufacturing, and Marketing teams to align regulatory activities with overall business goals.
  • Prepare, compile, and submit Controlled Correspondence, Pre-submission Meeting Requests, and Scientific Advice for US, EU, Canada, and other global markets.
  • Evaluate change controls, deviations, OOS/OOT events, and other quality incidents to assess regulatory impact.
Required Skills and Qualifications

To succeed in this role, you will require:

  • A Master of Pharmacy degree (M.Pharm) or equivalent qualification.
  • At least 12 years of experience in regulatory affairs, with a strong track record of success in developing and implementing global regulatory strategies.
  • Excellent communication and project management skills, with the ability to work effectively in a cross-functional team environment.
Benefits

This is an excellent opportunity to join a leading organization and contribute to the development of innovative medical devices and solutions that have empowered millions of women worldwide.

You will be part of a dynamic team that values collaboration, innovation, and excellence, and offers a competitive salary and benefits package.

As a Regulatory Affairs Manager, you will have the opportunity to work on high-profile projects and make a real impact on our business.

Our organization is certified under ISO 9001, ISO 14001, WHO GMP, CE, and ISO 13485 standards.

We offer a positive and inclusive work environment, with opportunities for professional growth and development.

We are committed to diversity, equity, and inclusion, and welcome applications from talented individuals from diverse backgrounds.

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