Regulatory Affairs Manager/Senior Manager-(EP) Full Time NEW

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

Responsibilities

Regulatory Strategy & Leadership

• Develop and execute regulatory strategies for new registrations and lifecycle activities
• across all regions.
• Lead all aspects of EU regulatory submissions, including CP, DCP, MRP, national procedures, variations, renewals, post-approval commitment and line extensions.
• Anticipate regulatory risks, propose mitigation plans, and support business decision‑making.
• Oversee preparation, review, and submission of CTD/eCTD dossiers (Modules 1–5) globally.
• Coordinate global roll‑out activities with affiliates and partners, ensuring alignment with Core dossiers and CCDS updates.
• Lead responses to regulatory questions, deficiency letters, and compliance requests.
• Coordinate EU‑PI updates and harmonization with local labels worldwide.

Regulatory Compliance & Intelligence

• Monitor evolving regulatory requirements in EU and international markets and proactively communicate impacts.
• Ensure global regulatory activities comply with applicable regulations, company SOPs, and quality systems.
• Contribute to regulatory intelligence, sharing insights with internal teams.

Cross‑Functional Collaboration

• Partner with Clinical, CMC, Pharmacovigilance, Medical Affairs, Supply Chain, and Commercial functions to ensure aligned and efficient regulatory execution.
• Support decision‑making with clear regulatory perspectives on development, risk management, and lifecycle planning.

Leadership & Mentoring

• Provide leadership to regulatory team members, fostering expertise and strong execution capabilities.
• Mentor junior regulatory professionals and support organizational capability building.

Key Competencies

• Strategic and analytical thinking
• Strong communication and negotiation skills
• Ability to manage multiple stakeholders across geographies
• High sense of ownership, accountability, and decision‑making capability
• Team leadership and talent development mindset

Qualifications & Experience

• University degree in Life Sciences, Pharmacy, Medicine, or related field.
• 10–15+ years of regulatory affairs experience in the pharmaceutical industry.
• Extensive hands‑on experience with EU procedures (CP, DCP, MRP, national registrations).
• Demonstrated experience in global regulatory submissions and lifecycle management across multiple regions.
• Proven leadership and ability to collaborate in cross‑functional team environment.
• Experience engaging with EMA and national authorities.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies: PharmaLex India Private Limited

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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned