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Manager, Regulatory Affairs

ComplianceComplianceFull TimeRemoteSeniorTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

Vietnam

Posted

30 days ago

Salary

0

Seniority

Senior

English

Job Description

Manager, Regulatory Affairs

Recruiting.com

• 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 • 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

Job Requirements

  • Regulatory Affairs activities for lifecycle management of pharmaceutical products
  • Support change applications (Administrative, Labelling, Chemistry Manufacturing & Controls, Safety)
  • 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
  • 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

Benefits

  • 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.

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