Global Regulatory Affairs Lead

Vor 4 Tagen

Basel, Basel-Stadt, Schweiz Dr. Reddy's Laboratories Vollzeit
About the Role: We are seeking a highly skilled Regulatory Affairs Strategist to join our dynamic team and drive the regulatory strategy for new product developments.

We offer a collaborative and inclusive work environment where you can grow your career and contribute to the success of our organization. As a member of our team, you will be responsible for developing and implementing regulatory strategies to ensure the successful approval and launch of new products.

The ideal candidate will have a deep understanding of regulatory requirements for medicinal products and strong strategic thinking and problem-solving skills. You will be able to work effectively in a fast-paced environment and communicate complex ideas clearly.

Key Responsibilities:
  1. Regulatory Strategy Development:
    1. Formulate comprehensive regulatory strategies for new product developments, ensuring alignment with business goals and regulatory requirements.
    2. Provide expert regulatory advice and support to project teams throughout the product development lifecycle.
    3. Identify potential regulatory hurdles and develop mitigation plans to address them.
    4. 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) to obtain approval for marketing new products in different regions.
    2. Coordinate with cross-functional teams to gather necessary data and documentation for regulatory submissions.
    3. Track submission deadlines and manage the submission process to avoid delays.
    4. Maintain accurate and up-to-date records of all regulatory submissions, including copies of submitted documents, correspondence with regulatory agencies, and approval letters.
    5. Ensure proper documentation of submission strategies, timelines, and outcomes.
  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.
    3. Respond promptly to any queries or requests for additional information from regulatory authorities.
    4. Monitor the status of regulatory submissions and follow up with regulatory agencies as needed.
    5. Address any issues or concerns raised by regulatory authorities during the review process and ensure remediation within the cross-functional team.
  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.
  5. Cross-Functional Collaboration:
    1. Work closely with R&D, Quality Assurance, Medical Affairs, and Marketing teams to ensure regulatory requirements are integrated into product development processes.
    2. Provide regulatory input during product design and development stages to ensure compliance and facilitate smooth regulatory approvals.
  6. New Claims Evaluation and Implementation:
    1. Evaluate new product claims to ensure they meet regulatory requirements and are supported by scientific evidence in collaboration with marketing, medical, and R&D teams.
    2. Formulate the relevant regulatory strategy for the new product claims implementation and execute the implementation strategy.

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