
Associate Director - Global Regulatory Strategy, Immunology
Welcome to Bristol-Myers Squibb, a leading global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. We are currently seeking a highly motivated and experienced individual to join our team as the Associate Director of Global Regulatory Strategy for our Immunology portfolio. As the Associate Director, you will play a critical role in shaping and executing the global regulatory strategy for our Immunology products, collaborating closely with cross-functional teams to ensure successful development and commercialization. This is an exciting opportunity to be a part of a dynamic and fast-paced environment, where you can make a meaningful impact on the lives of patients worldwide. To excel in this role, you will need a strong background in regulatory affairs, a deep understanding of the Immunology space, and exceptional leadership skills. If you are passionate about driving regulatory strategy and making a difference in the lives of patients, we encourage you to apply for this position.
- Develop and execute global regulatory strategies for the Immunology portfolio, ensuring alignment with company objectives and regulatory requirements.
- Collaborate with cross-functional teams, including R&D, clinical development, commercial, and medical affairs, to drive successful development and commercialization of Immunology products.
- Stay current with industry trends and changes in regulations to inform and adapt global regulatory strategy.
- Provide guidance and expertise on regulatory requirements and potential risks for the Immunology portfolio.
- Lead regulatory interactions and submissions with health authorities globally.
- Serve as the point of contact for regulatory issues and inquiries related to the Immunology portfolio.
- Monitor and assess the impact of regulatory changes on the Immunology portfolio and communicate updates to relevant stakeholders.
- Provide leadership and mentorship to junior team members within the regulatory affairs department.
- Participate in cross-functional meetings and committees to ensure alignment and collaboration across departments.
- Represent the company at external meetings and conferences related to Immunology regulatory affairs.
- Develop and maintain relationships with key stakeholders and regulatory agencies.
- Ensure compliance with relevant laws, regulations, and company policies.
- Identify and implement process improvements to streamline regulatory processes and increase efficiency.
- Communicate progress and updates on regulatory activities to senior management.
- Serve as a subject matter expert on Immunology products for internal and external stakeholders.
Advanced Degree In A Related Scientific Field, Such As Pharmacology, Biotechnology, Or Immunology.
Minimum Of 7-10 Years Of Experience In Global Regulatory Affairs Within The Pharmaceutical Industry, With A Focus On Immunology Products.
Strong Understanding Of Global Regulatory Requirements And Guidelines, Including Fda, Ema, And Other Regional Regulatory Bodies.
Proven Track Record Of Successfully Developing And Executing Global Regulatory Strategies For Immunology Products, Including Biologics And Small Molecules.
Excellent Communication And Leadership Skills, With The Ability To Collaborate Effectively With Cross-Functional Teams And External Stakeholders To Drive Regulatory Success.
Product Development
Strategic Planning
Project Management
Global regulations
Team Leadership
Risk assessment
Regulatory compliance
Cross-Functional Collaboration
Regulatory Submissions
Immunology Expertise
Labeling Strategy
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Associate Director - Global Regulatory Strategy, Immunology in Summit, NJ, USA is $160,000 - $190,000 per year. However, this can vary depending on the individual's experience, education, and the specific company they work for. Some companies may offer higher salaries or additional benefits such as bonuses or stock options. It is important to research the specific company and industry before accepting a job offer.
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Bristol-Myers Squibb Co. operates as a biopharmaceutical company, which engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. It includes chemically-synthesized drugs or small molecules and products produced from biological processes called biologics.

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