Senior Director Regulatory Affairs Liaison

Welcome to Merck & Co., a global leader in the pharmaceutical industry. We are currently seeking a highly skilled Senior Director Regulatory Affairs Liaison to join our team. In this role, you will play a pivotal role in ensuring our products meet all regulatory requirements and are in compliance with global regulations. As a Senior Director, you will have the opportunity to lead a team and collaborate with cross-functional teams to develop and execute regulatory strategies. We are looking for a driven individual with strong leadership abilities and a deep understanding of global regulatory affairs. If you are passionate about making a difference in the lives of patients and have a proven track record of success in regulatory affairs, we encourage you to apply.

1. Develop and execute regulatory strategies for global markets to ensure compliance with all relevant regulations and guidelines.
2. Lead a team of regulatory affairs professionals, providing guidance and support to ensure timely and accurate submission of regulatory documents.
3. Collaborate with cross-functional teams, including R&D, clinical development, manufacturing, and marketing, to ensure alignment and smooth execution of regulatory strategies.
4. Stay up-to-date on changes and updates to global regulatory requirements and communicate potential impacts to relevant teams.
5. Build and maintain relationships with regulatory agencies, representing the company in all interactions and negotiations.
6. Prepare and submit regulatory submissions, including INDs, NDAs, and post-approval filings, in accordance with applicable regulations and timelines.
7. Provide guidance and support to ensure compliance with labeling requirements, including product labeling and advertising/promotional materials.
8. Develop and maintain regulatory policies and procedures to ensure consistency and compliance across all products and markets.
9. Act as a subject matter expert in global regulatory affairs, providing guidance and support to internal teams and external partners.
10. Manage and monitor budgets and resources to ensure efficient and effective use of company resources.
11. Maintain a high level of knowledge and understanding of the pharmaceutical industry and relevant regulations, sharing insights and best practices with the team.
12. Mentor and coach team members, fostering a culture of continuous learning and development.
13. Represent the company in external meetings, conferences, and industry events, promoting the company's regulatory capabilities and expertise.
14. Drive continuous improvement initiatives within the regulatory affairs function, identifying areas for improvement and implementing solutions to enhance efficiency and effectiveness.

According to JobzMall, the average salary range for a Senior Director Regulatory Affairs Liaison in North Wales, PA 19454, USA is $190,000-$210,000 per year. This range may vary depending on the specific company, industry, and level of experience of the individual. Additional factors such as bonuses, benefits, and geographic location may also impact the overall 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.