Regulatory Affairs Leader

2 weeks ago

Dholka, Gujarat, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,02,50,000
Regulatory Leadership Role

As a seasoned Senior General Manager, you will lead our regulatory affairs team, driving strategic initiatives that ensure compliance with ever-changing regulations and standards.

Key Responsibilities:

  • Liaise with government agencies to facilitate coordination between customers, consultants, and internal stakeholders.
  • Provide expert guidance on regulatory submissions, ensuring timely and accurate delivery of high-quality documents.
  • Develop and implement effective strategies for regulatory engagement, collaboration, and risk management during business development discussions with international partners and cross-functional teams.
  • Guide the regulatory and quality teams to optimize their performance, identifying areas for improvement and assigning additional responsibilities based on team members' capabilities.
  • Coordinate compliance preparations for GMP audits at our facilities, ensuring seamless execution and minimal disruptions.
  • Facilitate the implementation of systems for regulatory expectations and compliance across cross-functional departments.
  • Review technical reports and investigation findings to ensure adherence to regulatory guidelines and provide actionable recommendations to cross-functional teams on documentation requirements.
  • Evaluate day-to-day operational issues regarding regulatory implications and offer short-term and long-term mitigation measures to minimize risks.

Required Skills and Qualifications:

  • Extensive experience in regulatory affairs, including liaison with government bodies and cross-functional teams.
  • Strong analytical and problem-solving skills, with ability to interpret complex regulations and develop effective strategies.
  • Excellent communication and interpersonal skills, with ability to collaborate with diverse stakeholders.
  • Proven track record of driving regulatory compliance and improving team performance.

Benefits:

  • Opportunity to work in a dynamic and challenging environment, driving strategic initiatives and promoting regulatory excellence.
  • Collaborative and supportive team culture, fostering growth and development.
  • Competitive compensation and benefits package, reflecting your value to the organization.

Others:

Our organization is committed to providing a safe and inclusive work environment, where employees feel valued and empowered to contribute to our success.

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