Senior Manager Regulatory Affairs

This job profile description is a standardized non-contractual reference description and global reference tool provided for organizational consistency and talent architecture purposes across Cencora. It does not alter actual job duties responsibilities reporting lines working conditions grading compensation or other essential terms and conditions of duties and responsibilities may vary based on business needs local requirements and operational practices. Where a team members role is governed by an employment agreement local terms and conditions prior job description or collective bargaining agreement those documents shall prevail in case of any inconsistency. Mandatory local laws shall also client engagements and work products related to pharmacovigilance safety surveillance risk management and related scientific consulting services within defined scope quality and timeline case processing documentation reporting activities and operational handoffs to support accurate timely and compliant safety safety data literature and other relevant information to support signal detection signal assessment and fit-for-purpose client development and maintenance of risk management deliverables benefit-risk assessments and related regulatory documentation across the product and implements improvements to procedures templates and workflow controls that improve quality reduce rework and strengthen compliance within the job coordination with client stakeholders and internal partners to confirm requirements resolve routine issues and maintain alignment to service expectations and less-experienced professionals through practical application of standards documentation expectations and reusable ways of working.

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Bachelors degree in life sciences pharmacy medicine nursing public health epidemiology regulatory affairs or a related field or equivalent experience required.4 years of experience in pharmacovigilance drug safety epidemiology risk management scientific consulting regulatory affairs or a related field in pharmacovigilance drug safety preferred. Certification in regulatory affairs clinical safety preferred. Certification in quality management auditing preferred.

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: PharmaLex Spain S.L.U.

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