Merck & Co.

Associate Director, Regulatory Affairs

Merck & Co.

West Point, PA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

At Merck & Co., we are committed to making a difference in the lives of patients around the world. Our team of passionate and dedicated professionals work tirelessly to develop and deliver innovative medicines and vaccines that improve and save lives. We are currently seeking an experienced and driven individual to join our team as Associate Director, Regulatory Affairs.As the Associate Director, you will play a critical role in ensuring compliance with regulatory requirements and securing approval for our life-saving products. You will work closely with cross-functional teams, providing strategic regulatory guidance and overseeing the preparation and submission of regulatory documents. To excel in this role, you must have a strong understanding of global regulatory requirements, excellent communication skills, and the ability to collaborate effectively with diverse stakeholders.If you are looking for a challenging and rewarding opportunity to use your expertise in regulatory affairs to make a meaningful impact, we encourage you to apply for this role and join our mission-driven organization at Merck & Co.

  1. Develop and implement regulatory strategies to ensure compliance with global regulations and secure approval for our products.
  2. Lead and manage the preparation and submission of regulatory documents, including INDs, NDAs, BLAs, and other relevant documentation.
  3. Collaborate with cross-functional teams to provide strategic regulatory guidance throughout the product development process.
  4. Stay up-to-date with changes in global regulatory requirements and ensure timely implementation of any necessary changes.
  5. Serve as the main point of contact for regulatory agencies and represent the company in meetings and interactions with regulatory authorities.
  6. Conduct regulatory risk assessments and advise on potential regulatory issues that may impact product development and approval.
  7. Maintain and update regulatory submissions and ensure timely responses to regulatory agency requests.
  8. Train and mentor junior regulatory team members to ensure a high level of regulatory expertise within the organization.
  9. Participate in the development and review of company policies and procedures related to regulatory affairs.
  10. Collaborate with internal and external stakeholders to ensure alignment and consistency in regulatory strategies and submissions.
  11. Communicate effectively with all levels of the organization, including senior management, to provide updates on regulatory matters and seek input on regulatory strategies.
  12. Represent the company in industry forums and conferences to stay informed about industry trends and best practices in regulatory affairs.
  13. Ensure compliance with company values, policies, and procedures at all times.
  14. Contribute to the continuous improvement of regulatory processes and systems to enhance efficiency and effectiveness.
  15. Comply with all applicable laws, regulations, and company policies.
Where is this job?
This job is located at West Point, PA, USA
Job Qualifications
  • Bachelor's Or Advanced Degree In Life Sciences, Pharmacy, Or Related Field

  • 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

  • Proven Track Record Of Successfully Leading And Managing Regulatory Submissions And Approvals

  • Strong Communication And Leadership Skills, With The Ability To Collaborate Effectively With Cross-Functional Teams And Regulatory Agencies.

Required Skills
  • Project Management

  • Clinical Research

  • Drug development

  • Regulatory compliance

  • FDA regulations

  • Cross-Functional Collaboration

  • Regulatory Affairs

  • Regulatory Submissions

  • Regulatory Strategy

  • Pharmaceutical Industry

  • Global Submissions

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Time management

  • creativity

  • Attention to detail

  • Teamwork

  • Adaptability

  • Problem-Solving

  • Empathy

Compensation

According to JobzMall, the average salary range for a Associate Director, Regulatory Affairs in West Point, PA, USA is $120,000 to $150,000 per year. This may vary depending on the individual's experience, education, and the specific company they work for.

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 PostedJanuary 3rd, 2024
Apply BeforeAugust 19th, 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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