HomeHead/VP/CEO/President/GMHead Regulatory Affairs | Abbott Laboratories | Mumbai

Head Regulatory Affairs | Abbott Laboratories | Mumbai

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Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

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The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Position: Head – Regulatory Affairs

Location: Mumbai, Maharashtra, India

Job Description:

The main purpose of this role :

  • Manages teams within the Regulatory Affairs Sub-Function.
  • The focus is on policy and strategy implementation and control rather than development.
  • Typically handles short-term operational/tactical responsibilities.

Main Responsibilities :

  • As the Manager of the Regulatory Affairs Sub-Function oversees the strategy implementation and operations for directing the development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

  • Interacts with regulatory agencies to expedite approval of pending registration.
  • Serves as a regulatory liaison throughout the product lifecycle.
  • Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
  • Ensures timely approval of new drugs, biologics, or medical devices, and continued approval of marketed products.
  • Serves as a regulatory representative to marketing, research teams, and regulatory agencies.
  • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.

Qualification: M.Sc / B.Pharm / M.Pharm / Ph.D in Pharmacy

Experience: 14 – 16 years in regulatory affairs mainly for emerging markets. Having exposure to the US / EU will be an added advantage.

Salary: Negotiable

Contcat Details:

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