Regulatory Affairs Manager

About the Company

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, market development and effective product maintenance.

Responsibilities

• Regulatory Affairs activities for lifecycle management of pharmaceutical products including support for change applications (administrative, labelling, CMC, safety) and submission strategy
• Dossier compilation including preparation of documents (e.g. local forms, cover letters) and Table of Contents
• Content review of Chemistry, Manufacturing & Controls (CMC), labelling and justification documents
• Align with functions on variation procedures and deficiency letters (e.g., CMC, Medical Science, publishing team)
• Update/local product information and labelling translation; check regulatory compliance of product information and artworks
• Manage marketing authorisation activities: withdrawal, MA holder transfer, licence renewal
• Contribute to Periodic Safety Update Reports
• Invoice checks (e.g., authority invoices) and request translations/additional Module 1 documents (e.g., Quality Practices declaration, Good Manufacturing Practices)
• Databases maintenance: archiving and tracking
• Manage local regulatory affairs requirements and local regulatory intelligence
• Use national competent authorities' electronic submission systems as required
• Act as contact with local Health Authority on behalf of the client
• Cross-functional communication with relevant departments regarding regulatory strategy, submissions and lifecycle management issues
• Support Country Regulatory Affairs Head in issue management (e.g., product quality control standards, safety issues such as stock-outs, Dear Healthcare Professional Letter preparation, coordination and submission per local regulations and company SOPs)
• Represent Regulatory Affairs in internal meetings and committees
• Review promotional materials

What Cencora offers

• Benefit offerings outside the US may vary by country and will be aligned to local market practice; eligibility and effective dates may differ for some benefits and for team members covered under collective bargaining agreements
• Full time

Additional Information

• Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic