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Manager, Regulatory Affairs

Pharmalex
PharmaLex
5+ years
Not Disclosed
10 Oct. 29, 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

Your Job:
As a Manager in Regulatory Affairs, you will be responsible for the evaluation, preparation, and compilation of documents related to pharmaceutical quality. This includes:

  • Document Management: Preparation of Active Substance Master Files, application documents for Certificates of Suitability, and Investigational Medicinal Product Dossiers, along with Quality Overall Summaries/Expert Reports for human medicinal products as part of the marketing authorization dossier.
  • Regulatory Compliance: Strong emphasis on meeting relevant technical and regulatory requirements, as well as customer-specific demands.
  • Strategy and Planning: Collaborate with the Business Development team on both new and ongoing projects, supporting the preparation of proposals for clients.
  • Project Management: Ensure quality, timelines, and customer satisfaction throughout project execution; conduct gap analyses based on requirements.
  • Lifecycle Management: Provide regulatory support to clients for their products throughout their lifecycle.
  • Coordination and Communication: Liaise with project teams, customers, internal departments, suppliers, local partners, and regulatory bodies to facilitate essential operational procedures.
  • Process Optimization: Assist in optimizing internal departmental processes to enhance efficiency.
  • Knowledge Sharing: Proactively present and distribute relevant technical knowledge, including SOP training for both the organization and clients as required.
  • Additional Tasks: Handle any other tasks that require regulatory inputs for all types of products across various markets.

Your Profile:

  • Graduate/Post-graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent.
  • Minimum of 5 years of professional experience within the pharmaceutical industry in Regulatory Affairs.
  • Ability to work autonomously with a focus on quality and detail.
  • Strong teamwork skills and a sense of responsibility.
  • Excellent command of English.
  • In-depth knowledge of current legal and regulatory requirements in developed markets (Japan, USA, and EU).
  • Ability to manage and prioritize multiple tasks, especially under tight deadlines.
  • Strong organizational and communication skills.
  • High degree of social competence with experience in virtual teams and matrix organizations.