Regulatory Affairs Lead Director

McKesson Corporation is seeking a highly motivated and experienced individual to join our team as the Regulatory Affairs Lead Director. As a global leader in healthcare, our company is committed to ensuring compliance with all regulatory requirements to deliver safe and effective products to our customers. We are looking for a dynamic and strategic leader who can effectively navigate the ever-changing regulatory landscape and drive continuous improvement in our regulatory processes. If you are passionate about making a positive impact in the healthcare industry and possess the necessary qualifications, we invite you to join us in our mission to improve patient outcomes and enhance the quality of care.

1. Develop and implement regulatory strategies and policies to ensure compliance with all applicable laws and regulations.
2. Stay up-to-date on all relevant regulatory changes and updates, and communicate their impact to relevant stakeholders.
3. Lead and manage a team of regulatory affairs professionals, providing guidance and support to ensure timely and accurate submissions to regulatory agencies.
4. Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product development processes.
5. Prepare and submit regulatory filings, including applications, reports, and other required documents, in a timely and accurate manner.
6. Serve as the primary point of contact for all regulatory agencies and ensure timely and effective communication.
7. Conduct risk assessments and develop risk mitigation strategies to proactively address potential regulatory issues.
8. Monitor and track product complaints and adverse events, and ensure appropriate reporting to regulatory agencies.
9. Lead and participate in regulatory inspections and audits, and implement corrective actions as needed.
10. Develop and maintain strong relationships with internal and external stakeholders, including regulatory agencies, industry associations, and key opinion leaders.
11. Provide regulatory guidance and support to other departments, including marketing, sales, and quality assurance.
12. Identify opportunities for process improvement and lead initiatives to enhance regulatory processes and procedures.
13. Ensure compliance with internal policies and procedures related to regulatory affairs.
14. Represent the company in industry conferences and meetings to stay informed about regulatory trends and best practices.
15. Uphold the company's commitment to delivering safe and effective products to customers by ensuring compliance with all regulatory requirements.

According to JobzMall, the average salary range for a Regulatory Affairs Lead Director in Irving, TX, USA is between $150,000 and $200,000 per year. This can vary depending on the specific industry, company size, and level of experience.

Celesio AG is a healthcare and pharmaceutical company, based in Stuttgart, Germany. The company operates in 14 countries around the world and generated revenue of more than 22,000 million euros in 2014. The corporation is part of the American McKesson Corporation who has a 76% stake in the company.