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Regulatory Affairs Strategist Director

vor 1 Woche

Basel, Basel-Stadt, Schweiz Dr. Reddy's Laboratories Vollzeit
About Us: Dr. Reddy's Laboratories is a rapidly expanding consumer healthcare business with a strong European presence. We are committed to delivering high-quality products and exceptional value to our customers. Our mission is to make a meaningful difference in the lives of patients around the world by providing innovative solutions that improve healthcare outcomes.

We are seeking a talented and motivated Regulatory Affairs Strategist to join our dynamic team and contribute to our growth journey. As a member of our team, you will have the opportunity to work on challenging projects, develop your skills, and build a successful career.

Job Summary: The Regulatory Affairs Strategist will be responsible for developing and implementing regulatory strategies to ensure the successful approval and launch of new products. This role requires a deep understanding of regulatory requirements for medicinal products, strong strategic thinking, and excellent communication skills. You will work closely with cross-functional teams to ensure regulatory requirements are integrated into product development processes and provide regulatory input during product design and development stages.

Key Responsibilities:
  1. Regulatory Strategy Development:
    1. Develop comprehensive regulatory strategies for new product developments, ensuring alignment with business goals and regulatory requirements.
    2. Collaborate with cross-functional teams to identify potential regulatory hurdles and develop mitigation plans.
    3. Assess the impact of regulatory changes on new product developments and update strategies accordingly.
  2. Regulatory Submissions:
    1. Evaluate, compile, prepare, review, and submit regulatory documents for Marketing Authorization Applications (MAA).
    2. Coordinate with regulatory agencies to gather necessary data and documentation for regulatory submissions.
    3. Track submission deadlines and manage the submission process to avoid delays.
  3. Communication with Regulatory Agencies:
    1. Serve as the primary point of contact with regulatory agencies for regulatory submissions.
    2. Maintain open and effective communication with regulatory agencies throughout the submission process.
  4. Compliance and Risk Management:
    1. Ensure all new products comply with applicable regulations, standards, and guidelines.
    2. Conduct risk assessments and develop risk management plans to address potential regulatory issues.