Director - US Regulatory Affairs Liaison

Hanover, NJ, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

At Bayer, we are committed to improving the lives of people around the world through our innovative healthcare solutions. As our Director of US Regulatory Affairs Liaison, you will play a crucial role in ensuring our products meet all necessary regulatory requirements for approval and market access in the United States. We are looking for a highly experienced and driven individual with a deep understanding of the pharmaceutical industry and a strong network within the US regulatory landscape. If you are passionate about making a positive impact on patients' lives and are ready to take on a leadership role in a dynamic and fast-paced environment, we invite you to apply for this exciting opportunity.

Develop and implement strategies to ensure timely and successful regulatory approvals for Bayer's healthcare products in the United States.
Serve as the primary point of contact between Bayer and U.S. regulatory authorities, including the FDA, to facilitate communication and collaboration.
Stay up-to-date on all relevant regulatory requirements and changes in the U.S. healthcare landscape to ensure compliance and mitigate any potential risks.
Build and maintain strong relationships with key stakeholders in the U.S. regulatory environment, including government agencies, industry associations, and advocacy groups.
Lead a team of regulatory affairs professionals to effectively manage and navigate the complex U.S. regulatory process.
Collaborate with cross-functional teams within Bayer, including R&D, marketing, and legal, to ensure alignment and integration of regulatory strategies.
Provide strategic input and guidance to senior leadership on regulatory matters and potential implications on business strategy.
Proactively identify and address potential regulatory challenges or roadblocks and develop contingency plans to mitigate risks.
Represent Bayer in industry forums and conferences related to U.S. regulatory affairs, and serve as a subject matter expert for internal and external stakeholders.
Foster a culture of compliance and continuous improvement within the regulatory affairs team, ensuring all activities and processes adhere to relevant laws, regulations, and industry standards.

Where is this job?

This job is located at Hanover, NJ, USA

Job Qualifications

Extensive Knowledge Of Us Regulatory Laws And Guidelines: The Director Of Us Regulatory Affairs Liaison Should Possess A Strong Understanding Of The Us Regulatory Landscape, Including Fda Regulations, Drug Development Processes, And Submission Requirements.
Experience In Pharmaceutical Or Biotechnology Industry: A Minimum Of 8-10 Years Of Experience In A Regulatory Affairs Role In The Pharmaceutical Or Biotechnology Industry Is Typically Required For This Position. This Ensures The Candidate Has A Thorough Understanding Of The Industry And Its Regulatory Processes.
Excellent Communication And Negotiation Skills: As A Liaison Between Bayer And Us Regulatory Authorities, The Director Must Possess Excellent Communication And Negotiation Skills To Effectively Convey Information And Negotiate On Behalf Of The Company.
Leadership And Management Experience: This Role Requires The Ability To Lead And Manage A Team Of Regulatory Affairs Professionals. Therefore, Experience In A Leadership Or Management Position Is Essential.
Strong Project Management Skills: The Director Of Us Regulatory Affairs Liaison Must Be Able To Effectively Manage Multiple Projects Simultaneously, Ensuring Timely And Successful Completion Of Regulatory Submissions And Approvals. Strong Project Management Skills, Including Organization, Time Management, And Attention To Detail, Are Crucial For This Role.

Required Skills

Quality Assurance
Drug development
Government Relations
Regulatory compliance
FDA regulations
Medical Devices
Cross-Functional Collaboration
Regulatory Affairs
Regulatory Submissions
Regulatory Strategy
Pharmaceutical Industry

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
flexibility
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Director - US Regulatory Affairs Liaison in Hanover, NJ, USA is $150,000 - $200,000 per year. This may vary depending on factors such as the specific company, the candidate's experience and qualifications, and the current job market.

Additional Information

Bayer 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 PostedJuly 23rd, 2024

Apply BeforeMay 22nd, 2025

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