Director Regulatory Affairs Liaison

Welcome to Merck & Co., a global pharmaceutical company dedicated to improving human health. We are seeking a dynamic and experienced individual to join our team as the Director of Regulatory Affairs Liaison. In this role, you will be responsible for establishing and maintaining positive relationships with regulatory agencies and ensuring compliance with all applicable regulations. As a key member of our regulatory affairs team, you will play a crucial role in bringing life-saving medicines to patients around the world. To be successful in this role, you must have a deep understanding of regulatory processes and requirements, excellent communication and leadership skills, and a passion for making a difference in the lives of patients. If you are looking for a challenging and rewarding opportunity to make an impact in the healthcare industry, we invite you to apply for the Director of Regulatory Affairs Liaison position at Merck & Co.

1. Develop and implement strategies to establish and maintain positive relationships with regulatory agencies at local, national, and international levels.
2. Ensure compliance with all applicable regulations and laws related to pharmaceutical products.
3. Serve as the primary point of contact for all regulatory agencies, responding to inquiries and requests in a timely and accurate manner.
4. Coordinate and facilitate meetings and communications between internal teams and regulatory agencies.
5. Stay up-to-date with changes in regulations and communicate any potential impact on the company's products or processes.
6. Provide guidance and support to cross-functional teams on regulatory requirements and processes.
7. Collaborate with internal stakeholders to develop and execute regulatory strategies for new product development and approval.
8. Prepare and submit regulatory submissions, including INDs, NDAs, and other applications, ensuring accuracy and completeness.
9. Conduct internal audits and ensure adherence to regulatory requirements.
10. Represent the company in external meetings and conferences related to regulatory affairs.
11. Monitor and track regulatory submissions and approvals, providing timely updates to senior management.
12. Mentor and guide junior members of the regulatory affairs team.
13. Continuously identify areas for process improvement and implement changes to increase efficiency and compliance.
14. Foster a culture of compliance and ethical behavior within the organization.
15. Uphold the company's values and reputation in all interactions with regulatory agencies and external stakeholders.

According to JobzMall, the average salary range for a Director Regulatory Affairs Liaison in Rahway, NJ 07065, USA is between $150,000 and $200,000 per year. This can vary depending on the specific company, level of experience, and other factors. Some companies may offer a higher salary for this position, while others may offer a lower salary. It is also important to consider other benefits and compensation packages that may be included in the overall compensation for this role.

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.