Director/Consultant, Regulatory Affairs

AmerisourceBergen; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

Join an innovative company dedicated to improving health outcomes for people and animals. This role offers the opportunity to lead regulatory affairs initiatives, manage client interactions, and drive business growth through strategic partnerships. With a focus on continuous learning and professional development, you will be part of a team that values your contributions and supports your career aspirations. If you're passionate about making a difference in the healthcare industry, this position is perfect for you!

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Wellness Programs

Professional Development

Mentorship Opportunities

Paid Parental Leave

Adoption Assistance

Backup Dependent Care

Qualifications

• 12+ years of experience in regulatory affairs or related functions.
• Broad understanding of international regulations and processes.
• Proficiency in project management and leadership.

Responsibilities

• Lead client proposals and generate new business.
• Manage multiple projects to meet budget and timelines.
• Develop and maintain partnerships with senior decision-makers.

Skills

Project Management

Regulatory Affairs

Strategic Planning

Communication Skills

Leadership

Problem Solving

Business Acumen

Education

B.Sc. in Life Sciences

Advanced Degree in Related Field

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat

Microsoft Outlook

Job 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

PRIMARY DUTIES AND RESPONSIBILITIES:

1. Responsible for preparing client proposals and generating new business for TPIreg, including leading presentations to potential RA clients, and participating in multifunctional presentations.
2. Prioritize and manage multiple simultaneous projects to meet budget (including invoice review), timelines, and client expectations; anticipate and resolve emerging issues.
3. Responsible for development and implementation of RA activities including assessments, strategies, submissions, and agency interactions, applying expert knowledge in core area of regulatory practice (e.g., CMC, Medical Devices, CTAs, US) and at least basic knowledge outside of core area.
4. Maintain target billables by obtaining new business.
5. Create opportunities to build agency relationships by participating in professional activities such as offering industry training, conference presentations, publications, and webinars.
6. Lead client and agency interface, with responsibility for strengthening relationships and growing the business. Ensure the quality of deliverables by ensuring compliance with Innomar and client review and approval processes; identify and implement opportunities for process improvement.
7. Develop and maintain partnerships with senior decision-makers to build the business, resolve significant issues, and create opportunities.
8. Analyze data, the regulatory environment, and business objectives to make and implement recommendations, using judgment to identify innovative solutions while managing uncertainty.
9. Lead and advise clients and cross-functional teams on agency interactions. Lead decision-making and conflict resolution surrounding regulatory issues within cross-functional teams.
10. Proactively identify, share, and interpret regulatory intelligence.
11. Manage multiple simultaneous projects to ensure they are on budget, meet timelines, and client expectations.
12. Engage in continuous learning activities to provide effective consulting services and be a sought-after resource.
13. Develop and manage 0-2 regulatory direct reports at Manager level or below, including assignment delegation, time and budget management, and skill development.
14. Travel as required.
15. Other related duties as assigned.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• B.Sc. degree in life sciences (e.g., Pharmacology, Molecular Biology, Biology, Chemistry, or Pharmacy) or Engineering.
• Advanced Degree in related field is preferred.
• 12+ years of relevant experience in regulatory affairs or related functions in pharmaceutical/biologic/medical device development/manufacturing. In-depth experience in a designated area of specialization (e.g., Medical devices, clinical trials, CMC) may be required.
• Regulatory Affairs Certification (RAC) and other certifications are assets.
• Prior consulting experience is preferred.
• Leadership skills required.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Broad understanding of international regulations, processes, and issues in drug/biologics/medical device development, including knowledge of ICH, Health Canada, FDA, EMA, and other relevant guidelines, with focus in areas such as CMC, biologics, pharmaceuticals, Clinical Trials, OTC/NHPs, medical devices, or FDA.
• In-depth experience managing Health Authorities interactions on a regional basis.
• Expertise in the regulatory specialization required for the role, such as medical devices, CMC, or advertising/promotion.
• Extensive experience with a wide range of regulatory submission types.
• Superior project management skills to handle multiple concurrent projects within timelines in a dynamic environment.
• Advanced strategic planning and complex problem-solving skills to resolve issues efficiently and effectively.
• Demonstrated senior leadership abilities in a cross-disciplinary team environment.
• Strong business and financial acumen.
• Excellent communication skills, both oral and written.
• Excellent presentation skills.
• Strong leadership and interpersonal skills.
• Effective organizational skills with attention to detail.
• Ability to meet deadlines consistently.
• Proficiency with computers, including Adobe Acrobat, Microsoft Word, Excel, and Outlook. Ability to develop professional networks for business development and regulatory intelligence.

What Cencora offers

We provide compensation, benefits, and resources that promote an inclusive culture and support our team members’ purpose-driven lives. Benefits include medical, dental, vision, and a comprehensive suite of wellness programs covering physical, emotional, financial, and social aspects, including support for working families, backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health, paid parental and caregiver leave, and more. We also offer training, professional development, mentorship, employee resource groups, volunteer activities, and additional growth opportunities.

Full-time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or other protected classes. We ensure non-discrimination in recruiting, training, compensation, benefits, promotions, and transfers.

We provide reasonable accommodations for individuals with disabilities during the employment process. To request accommodations, contact 888.692.2272 or email [e-mail]. Accommodation requests are handled on a case-by-case basis. Messages and emails unrelated to accommodations will not be responded to.

Accessibility Policy

Cencora is dedicated to fair and accessible employment practices. We will accommodate individuals with disabilities during recruitment, assessment, hiring, and employment upon request.

Affiliated Companies

Innomar Strategies