AbbVie

Manager, Global Regulatory Strategy US & Canada (Hybrid Onsite)

AbbVie

San Francisco, CA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to AbbVie! We are a leading pharmaceutical company dedicated to developing innovative treatments for patients around the world. As the Manager of Global Regulatory Strategy for the US & Canada, you will play a crucial role in ensuring our products meet regulatory requirements and are available to those in need. This is a hybrid onsite role, providing the opportunity to work both in our office and remotely. We are seeking a highly qualified individual with a passion for driving regulatory success and making a positive impact in the healthcare industry. If you are a strategic thinker with strong leadership skills and a deep understanding of regulatory processes, we encourage you to apply and join our team.

  1. Develop and implement global regulatory strategies for products in the US and Canada, in line with company objectives and regulatory requirements.
  2. Stay up-to-date with regulatory guidelines and changes in the pharmaceutical industry, and communicate any potential impact to relevant stakeholders.
  3. Collaborate with cross-functional teams, including R&D, clinical, marketing, and legal, to ensure that regulatory requirements are met throughout the product development process.
  4. Serve as the primary point of contact for regulatory agencies in the US and Canada, and lead interactions, submissions, and negotiations as necessary.
  5. Monitor and track regulatory submissions, approvals, and post-marketing requirements to ensure compliance and timely completion.
  6. Provide guidance and support to regional regulatory teams to ensure consistency and adherence to global strategies.
  7. Lead and mentor team members, providing guidance and support to drive their professional growth and development.
  8. Develop and maintain strong relationships with key external stakeholders, including regulatory authorities, industry associations, and advocacy groups.
  9. Proactively identify potential regulatory risks and develop mitigation strategies to address them.
  10. Represent the company at industry conferences and events, sharing knowledge and best practices with peers and staying updated on emerging regulatory trends and practices.
Where is this job?
This job is located at San Francisco, CA, USA
Job Qualifications
  • Bachelor's Or Advanced Degree In A Relevant Field Such As Regulatory Affairs, Pharmaceutical Sciences, Or Life Sciences.

  • Minimum Of 7-10 Years Of Experience In Regulatory Affairs, With A Focus On Us And Canada Regulations.

  • Expert Knowledge Of Fda And Health Canada Regulations And Processes For Drug Development And Approval.

  • Experience With Global Regulatory Strategy Development And Implementation, Including Interactions With International Regulatory Agencies.

  • Strong Leadership And Communication Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And Drive Decision-Making Processes.

Required Skills
  • Quality Assurance

  • Strategic Planning

  • Project Management

  • Team Leadership

  • Risk assessment

  • Regulatory compliance

  • Stakeholder management

  • Cross-Functional Collaboration

  • Regulatory Submissions

  • Regulatory Intelligence

  • Health Authority Interactions

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Critical thinking

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Manager, Global Regulatory Strategy US & Canada (Hybrid Onsite) in San Francisco, CA, USA is $150,000 to $200,000 per year. This range may vary depending on factors such as the size and industry of the company, the candidate's experience and qualifications, and the current job market conditions. Additionally, the salary may also include bonuses, benefits, and other perks.

Additional Information
AbbVie 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 PostedFebruary 6th, 2025
Apply BeforeApril 11th, 2026
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About AbbVie

AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.

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