Merck & Co.

Director Regulatory Affairs Liaison

Merck & Co.

North Wales, PA 19454, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

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.

  1. Serve as the main point of contact for all regulatory matters for the company.
  2. Develop and implement regulatory strategies to ensure compliance with global regulations.
  3. Stay up-to-date on all relevant regulations and guidelines to ensure the company's products meet all requirements.
  4. Lead and manage a team of regulatory affairs professionals.
  5. Collaborate with cross-functional teams to drive successful regulatory submissions and approvals.
  6. Communicate with regulatory agencies and authorities as needed.
  7. Ensure timely and accurate submissions of all regulatory documents.
  8. Monitor and assess changes in regulatory requirements and communicate potential impacts to the company.
  9. Provide regulatory guidance and expertise to internal stakeholders and external partners.
  10. Oversee the preparation and submission of regulatory filings and reports.
  11. Participate in internal and external audits and inspections related to regulatory compliance.
  12. Develop and maintain relationships with key stakeholders in the regulatory community.
  13. Proactively identify and mitigate potential regulatory risks.
  14. Continuously improve and streamline regulatory processes to increase efficiency and effectiveness.
  15. Represent the company in industry conferences and events related to regulatory affairs.
Where is this job?
This job is located at North Wales, PA 19454, USA
Job Qualifications
  • 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.

Required Skills
  • Strategic Planning

  • Project Management

  • Risk assessment

  • Regulatory compliance

  • Cross-Functional Collaboration

  • Clinical Trials

  • Regulatory Strategy

  • Pharmaceutical Regulations

  • Global Submissions

  • Labeling Regulations

  • Fda Submissions

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Attention to detail

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

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.

Additional Information
Merck & Co. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMay 30th, 2024
Apply BeforeMay 22nd, 2025
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About Merck & Co.

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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