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Director, Regulatory Affairs CMC US

AmerisourceBergen is now Cencora! Explore our careers.

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Salary
$119k – $187k
Location
USA > FL > Remote, United States of America
Workplace
Remote
Type
Full-time
Department
Legal
Seniority
Director
Experience
10+ years
Education
Master
Source
Workday

Description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Role Summary CMC Director:


  • Provide strategic CMC regulatory leadership across complex client programs, supporting development, submissions and lifecycle activities.
  • Lead major client projects and act as a senior client-facing advisor, ensuring delivery against timelines, quality and financial objectives.
  • Drive regulatory strategy, health authority interactions and scientific advice activities using extensive CMC expertise.
  • Support business growth through proposal development, bid defenses, client relationship management and identification of new opportunities.
  • Contribute to Practice Area operational excellence, mentoring, coaching and development of team members.
  • Provides leadership and resource oversight for the US CMC team, ensuring appropriate staffing, capability development and delivery support across projects.
  • Supports business growth and operational performance through recruitment, coaching, utilization management and collaboration with Practice Area leadership.

Bachelor's degree in business administration, healthcare management, or a related field, or equivalent experience required. Master's degree in business administration, healthcare management, or a related field, or equivalent experience preferred. 10+ years of experience in scientific consulting, healthcare, life sciences, or a related field required. 5+ years of experience in a management capacity required. Certification in clinical research or regulatory affairs preferred. Certification in health economics, outcomes research, or real-world evidence methodologies preferred.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time

Salary Range*

$119,100 - 186,560

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

.

Affiliated Companies:

Affiliated Companies: Cencora Global Consulting Services US Corporation

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