Regulatory Affairs Manager

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval of the market development and any action of effective product maintenance.

Responsibilities:

• Regulatory Affairs activities for lifecycle management of pharmaceutical products including but not limited to:
• Support change applications (Administrative Labelling Chemistry Manufacturing & Controls Safety) including submission strategy
• Dossier compilation including preparation of documents (e.g. local forms Cover Letters) and Table of Contents
• Content review of Chemistry Manufacturing & Controls/Labelling documentation/Justification documents
• Alignment with functions on variation procedures deficiency letter e.g Chemistry Manufacturing Controls Medical Science publishing team
• Update/local Product Information (Labelling translation)
• Check regulatory compliance of product information/artworks
• Marketing Authorization withdrawal
• Marketing Authorization Holder transfer
• Licence renewal

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• Other Accountabilities:
  • Periodic Safety Update Report contribution
  • Invoice check (e.g. Authority invoices)
  • Request Translation/additional Module 1 documents e.g. Quality Practices declaration Good Manufacturing Practices
  • Databases maintenance: archiving tracking
  • Management of local Regulatory Affairs requirements (local regulatory intelligence)
  • National Competent Authorities electronic systems for submission as locally required
  • Contact with the local Health Authority on behalf of the client
  • Cross-functional communication to all relevant departments in relation to regulatory strategy and submission as well as issues related to Lifecycle Management activities
  • Support of Country Regulatory Affairs Head in issue management (e.g. Product Quality Controls Standards Quality Safety issues like stock out situations management Dear Healthcare Professional Letter preparation coordination and submission in accordance with local regulations and company Standard Operating Procedures represent Regulatory Affairs in internal meetings and committees)
  • Review of Promotional Materials

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.

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