Regulatory Affairs ManagerSenior Manager-(EP)

Cencora

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profile Job Location:

Noida - India

profile Monthly Salary: Not Disclosed
Posted on: 6 days ago
Vacancies: 1 Vacancy

Job Summary

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 decisionmaking.

  • Oversee preparation review and submission of CTD/eCTD dossiers (Modules 15) globally.

  • Coordinate global rollout activities with affiliates and partners ensuring alignment with Core dossiers and CCDS updates.

  • Lead responses to regulatory questions deficiency letters and compliance requests.

  • Coordinate EUPI 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.

CrossFunctional Collaboration

  • Partner with Clinical CMC Pharmacovigilance Medical Affairs Supply Chain and Commercial functions to ensure aligned and efficient regulatory execution.

  • Support decisionmaking 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 decisionmaking capability

  • Team leadership and talent development mindset

.

Qualifications & Experience

  • University degree in Life Sciences Pharmacy Medicine or related field.

  • 1015 years of regulatory affairs experience in the pharmaceutical industry.

  • Extensive handson 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 crossfunctional 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 companys 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 . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned


Required Experience:

Senior Manager

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 ...
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