
Director Regulatory Affairs Liaison
Welcome to Merck & Co., a leading pharmaceutical company dedicated to improving the lives of people around the world. We are seeking a Director Regulatory Affairs Liaison to join our dynamic team. In this role, you will serve as the primary point of contact for all regulatory matters and develop strategies to ensure compliance with global regulations. Your expertise and leadership will be vital in driving our products through the complex regulatory landscape. To excel in this position, you must have a deep understanding of regulatory requirements, excellent communication skills, and the ability to thrive in a fast-paced environment. If you are passionate about making a difference in the healthcare industry, we invite you to apply for this exciting opportunity.
- Serve as the main point of contact for all regulatory matters for the company.
- Develop and implement regulatory strategies to ensure compliance with global regulations.
- Stay up-to-date on all relevant regulations and guidelines to ensure the company's products meet all requirements.
- Lead and manage a team of regulatory affairs professionals.
- Collaborate with cross-functional teams to drive successful regulatory submissions and approvals.
- Communicate with regulatory agencies and authorities as needed.
- Ensure timely and accurate submissions of all regulatory documents.
- Monitor and assess changes in regulatory requirements and communicate potential impacts to the company.
- Provide regulatory guidance and expertise to internal stakeholders and external partners.
- Oversee the preparation and submission of regulatory filings and reports.
- Participate in internal and external audits and inspections related to regulatory compliance.
- Develop and maintain relationships with key stakeholders in the regulatory community.
- Proactively identify and mitigate potential regulatory risks.
- Continuously improve and streamline regulatory processes to increase efficiency and effectiveness.
- Represent the company in industry conferences and events related to regulatory affairs.
Minimum Of 8-10 Years Of Experience In Regulatory Affairs Within The Pharmaceutical Industry
In-Depth Knowledge Of Fda Regulations And Guidelines, As Well As International Regulatory Requirements
Bachelor's Or Master's Degree In A Relevant Field Such As Pharmacy, Biology, Or Chemistry
Strong Leadership And Communication Skills, With The Ability To Effectively Liaise With Regulatory Agencies And Cross-Functional Teams
Demonstrated Track Record Of Successful Submissions And Approvals For New Drug Applications And Post-Approval Supplements.
Strategic Planning
Project Management
Risk assessment
Regulatory compliance
Cross-Functional Collaboration
Clinical Trials
Regulatory Strategy
Pharmaceutical Regulations
Global Submissions
Labeling Regulations
Fda Submissions
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Director Regulatory Affairs Liaison in North Wales, PA 19454, USA is $135,000 - $160,000 per year. However, this can vary depending on the specific company, industry, and level of experience of the individual.
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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.

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