Director Regulatory Affairs Liaison- General Medicine

At Merck & Co., we are committed to improving the health and well-being of people around the world. As a global pharmaceutical company, we are dedicated to developing and delivering innovative medicines and vaccines to address some of the world's most pressing health challenges. We are seeking a highly motivated and experienced Director of Regulatory Affairs Liaison for our General Medicine division. In this role, you will play a critical role in ensuring compliance with regulatory requirements and driving the successful approval of our products. We are looking for a dynamic leader with strong expertise in regulatory affairs and a passion for making a difference in patients' lives. If you are driven, collaborative, and have a track record of success in the pharmaceutical industry, we encourage you to apply for this exciting opportunity.

• Oversee and manage all aspects of regulatory affairs for the General Medicine division, including the development and execution of regulatory strategies, submissions, and compliance.
• Serve as the primary point of contact for all regulatory agencies, ensuring timely and accurate communication and collaboration.
• Stay up-to-date on all relevant regulations and guidelines, and proactively identify potential issues or changes that may impact product approvals or compliance.
• Lead a team of regulatory affairs professionals, providing guidance, training, and support to ensure high-quality and efficient work.
• Collaborate with cross-functional teams, including R&D, clinical development, medical affairs, and commercial teams, to ensure alignment and integration of regulatory strategies.
• Develop and maintain relationships with key internal stakeholders, including senior leadership, to ensure alignment and support for regulatory initiatives.
• Represent the company at external meetings and conferences related to regulatory affairs, and provide expert guidance and insights to key stakeholders.
• Ensure all regulatory submissions are completed accurately and on time, including INDs, NDAs, and other regulatory filings.
• Monitor and assess the competitive landscape and provide recommendations for strategic actions to maintain a competitive advantage.
• Identify and mitigate potential risks related to regulatory affairs, and develop contingency plans to address any challenges or obstacles.
• Serve as a subject matter expert on all matters related to regulatory affairs, providing guidance and support to other departments and teams as needed.
• Foster a culture of compliance and continuous improvement within the regulatory affairs team, promoting a commitment to quality and excellence in all activities.

According to JobzMall, the average salary range for a Director Regulatory Affairs Liaison- General Medicine in Boston, MA, USA is between $180,000 and $230,000 per year. This can vary depending on the specific company, years of experience, and level of education.

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.