Manager, Regulatory Affairs

5+ years

Not Disclosed

Remote

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.

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Manager, Regulatory Affairs

Job Description

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