Executive Director, Regulatory Affairs

Welcome to Merck & Co, a global healthcare leader dedicated to improving the lives of people around the world. We are seeking a highly motivated and experienced Executive Director of Regulatory Affairs to join our team. In this role, you will have the opportunity to lead and shape our regulatory strategy and drive the successful approval of our innovative drug therapies. As a key member of our leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company. The ideal candidate will have a strong background in regulatory affairs, exceptional leadership skills, and a passion for making a difference in the lives of patients. If you are looking for a challenging and rewarding career in a dynamic and collaborative environment, we encourage you to apply for this exciting opportunity.

1. Develop and implement regulatory strategies in alignment with overall business objectives.
2. Lead and manage a team of regulatory professionals to ensure timely and successful submissions of drug applications to global regulatory agencies.
3. Provide expertise and guidance on global regulatory requirements, guidelines, and changes that may impact the company's products.
4. Collaborate with cross-functional teams, including R&D, clinical, and commercial, to ensure alignment and compliance with regulatory requirements.
5. Prepare and review regulatory submissions, including INDs, NDAs, and MAAs, for accuracy, completeness, and compliance with regulations and guidelines.
6. Monitor and track the progress of regulatory submissions and communicate any potential issues or delays to senior management.
7. Stay up-to-date on industry trends and changes in regulatory landscape to inform and adapt company strategies.
8. Build and maintain relationships with regulatory agencies to facilitate efficient communication and ensure a positive working relationship.
9. Identify potential risks and develop contingency plans to mitigate potential obstacles to regulatory approvals.
10. Oversee the development and maintenance of regulatory policies, procedures, and standards to ensure compliance with global regulations.
11. Provide regulatory guidance and training to internal teams and external partners as needed.
12. Represent the company in regulatory meetings and negotiations with regulatory authorities.
13. Participate in due diligence activities for potential partnerships and acquisitions.
14. Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities.
15. Serve as a key member of the company's leadership team and contribute to overall business strategy and growth.

According to JobzMall, the average salary range for a Executive Director, Regulatory Affairs in North Wales, PA 19454, USA is between $170,000 - $220,000 per year. This range can vary depending on the specific company, industry, and level of experience of the individual. Factors such as education, certifications, and bonuses may also impact the salary range.

Merck & Co., Inc., d.b.a. Merck Sharp & Dohme outside the United States and Canada, is an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world. Merck & Co., Inc. engages in the provision of health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. It operates through the following segments: Pharmaceutical, Animal Health, Alliances and Healthcare Services. The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the company or through joint ventures.