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Drug Regulatory Affairs Manager

5+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Regulatory Project Team Lead

Job Description:
As the Global Regulatory Project Team Lead, you will oversee regulatory activities related to product maintenance, divestment, and withdrawal submissions. This includes leading cross-functional teams, liaising with internal and external partners, and providing expert regulatory advice. Your responsibilities will include:

  • Leading the planning, preparation, and delivery of regulatory submissions and response documents for global and regional perspectives.
  • Maintaining core labeling documents, including Core Data Sheets, Core Patient Information Leaflets, EU SmPC, US PI, and packaging components, ensuring consistency with internal standards and SOPs.
  • Managing updates to core texts, ensuring timely communication and implementation by MCs, and documenting deviations.
  • Proactively liaising with internal functions and external partners for complex submissions.
  • Identifying and mitigating complex regulatory risks.
  • Serving as a delegate for the Global Regulatory Lead when needed.
  • Mentoring and training regulatory team members.
  • Maintaining up-to-date compliance records and document integrity for packaging component labeling and related documents.
  • Building strong relationships with internal and external customers and partners.

Minimum Requirements:

  • University Degree in Science or related discipline
  • 6-12 years of relevant regulatory experience, including license maintenance, labeling, and publishing in regulated markets
  • Strong leadership and cross-functional project team management skills
  • Excellent English communication skills (written and verbal)
  • Thorough scientific knowledge to understand regulatory issues
  • Experience working with teams across locations, especially in Europe and/or the USA

Skills and Capabilities:

  • Supplier and Partner Management
  • Project Management, Influencing, Problem Solving
  • Independence, Team Working, and Customer-Focused
  • Continuous Improvement Mindset

Interested candidates can forward their profiles to contact@covalenttrainings.com or reach us at +91-9848733309 / +91-9676828080 for further guidance.