Associate Director, Regulatory Affairs

Welcome to Merck & Co., where we are committed to saving and improving lives around the world. We are seeking a highly motivated and experienced individual to join our team as an Associate Director of Regulatory Affairs. In this role, you will have the opportunity to use your regulatory expertise to ensure the successful development, approval, and marketing of our innovative pharmaceutical products. As an integral member of our global regulatory affairs team, you will be responsible for developing and implementing regulatory strategies and ensuring compliance with all applicable regulations and guidelines. To be successful in this role, you must have a minimum of 8 years of experience in regulatory affairs within the pharmaceutical industry, as well as a Bachelor's degree in a scientific discipline. If you are passionate about making a difference in the healthcare industry and have a strong understanding of global regulatory requirements, we invite you to apply for this exciting opportunity. Join us and be a part of our mission to make a positive impact on the world.

1. Develop and implement regulatory strategies to ensure successful development, approval, and marketing of pharmaceutical products.
2. Ensure compliance with all applicable regulations and guidelines, including those from global regulatory bodies.
3. Serve as an integral member of the global regulatory affairs team, providing expertise and support to cross-functional teams.
4. Maintain a strong understanding of global regulatory requirements and stay updated on any changes or updates.
5. Collaborate with internal and external stakeholders to gather and evaluate data for regulatory submissions.
6. Prepare and review regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
7. Communicate with regulatory authorities to obtain timely approvals and resolve any issues or concerns.
8. Provide guidance and mentorship to junior regulatory affairs team members.
9. Participate in regulatory agency inspections and audits.
10. Monitor and assess the impact of new regulations and guidelines on the company's products and processes.
11. Ensure timely and accurate completion of regulatory documentation and reports.
12. Represent the company at regulatory meetings and conferences.
13. Continuously seek opportunities for process improvement and efficiency within the regulatory affairs function.
14. Adhere to ethical and professional standards in all interactions and communications.
15. Collaborate with cross-functional teams to ensure alignment and consistency in regulatory strategies and activities.
16. Keep abreast of industry trends and best practices in regulatory affairs.
17. Maintain accurate and up-to-date records and documentation related to regulatory submissions and activities.
18. Act as a subject matter expert on regulatory affairs within the company.
19. Proactively identify and mitigate potential risks and issues related to regulatory compliance.
20. Demonstrate a strong commitment to the company's mission of saving and improving lives around the world.

According to JobzMall, the average salary range for a Associate Director, Regulatory Affairs in Rahway, NJ 07065, USA is $130,000-$150,000 per year. This can vary depending on the specific job duties, experience level, and company size. Additionally, factors such as bonuses, benefits, and location can also impact the overall salary range for this position.

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.