
Associate Director, Regulatory Affairs
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.
- Develop and implement regulatory strategies to ensure compliance with global regulations and secure approval for our products.
- Lead and manage the preparation and submission of regulatory documents, including INDs, NDAs, BLAs, and other relevant documentation.
- Collaborate with cross-functional teams to provide strategic regulatory guidance throughout the product development process.
- Stay up-to-date with changes in global regulatory requirements and ensure timely implementation of any necessary changes.
- Serve as the main point of contact for regulatory agencies and represent the company in meetings and interactions with regulatory authorities.
- Conduct regulatory risk assessments and advise on potential regulatory issues that may impact product development and approval.
- Maintain and update regulatory submissions and ensure timely responses to regulatory agency requests.
- Train and mentor junior regulatory team members to ensure a high level of regulatory expertise within the organization.
- Participate in the development and review of company policies and procedures related to regulatory affairs.
- Collaborate with internal and external stakeholders to ensure alignment and consistency in regulatory strategies and submissions.
- Communicate effectively with all levels of the organization, including senior management, to provide updates on regulatory matters and seek input on regulatory strategies.
- Represent the company in industry forums and conferences to stay informed about industry trends and best practices in regulatory affairs.
- Ensure compliance with company values, policies, and procedures at all times.
- Contribute to the continuous improvement of regulatory processes and systems to enhance efficiency and effectiveness.
- Comply with all applicable laws, regulations, and company policies.
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.
Project Management
Clinical Research
Drug development
Regulatory compliance
FDA regulations
Cross-Functional Collaboration
Regulatory Affairs
Regulatory Submissions
Regulatory Strategy
Pharmaceutical Industry
Global Submissions
Communication
Conflict Resolution
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
Empathy
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.
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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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