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    Manager Regulatory Affairs

    Thermo Fisher Scientific
    2+ years
    Not Disclosed
    Bangalore
    10 Oct. 30, 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: Regulatory Affairs Team Lead
    Work Schedule: Standard (Mon-Fri)
    Environmental Conditions: Office

    Job Description:

    Summarized Purpose:
    Manages a team within the department, providing innovative solutions, regulatory expertise, and client interface to deliver strategic regulatory intelligence and guidance for product development from preclinical stages through registration and product optimization.

    Essential Functions:

    • Manage staff, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching, mentoring, employee counseling, and separations. Approve actions related to salary administration, hiring, corrective measures, and terminations. Review and approve time records, expense reports, leave requests, and overtime.
    • Serve as a subject matter expert, providing regulatory strategy advice and technical expertise to internal and external clients while ensuring quality performance for key client projects. Manage project budgeting and forecasting, and participate in or lead project meetings.
    • Finalize and review regulatory documents and submissions, identifying out-of-scope activities in contracts in a timely manner. Liaise with other departments to manage all aspects of contract modifications.
    • Collaborate with business development in pricing and securing new business, making presentations to clients, and developing proposal texts and budgets in coordination with other departments.
    • Provide staff with up-to-date legislation and guidance as it becomes available, ensuring compliance with relevant organizational and departmental SOPs and WPDs.

    Education and Experience:

    • Bachelor's degree or equivalent formal academic/vocational qualification.
    • Minimum of 8+ years of relevant experience, including 2+ years in a leadership role.

    Knowledge, Skills, and Abilities:

    • Strong communication and negotiation skills in English and local language (where applicable), both oral and written.
    • Solid understanding of global/regional/national regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management.
    • Thorough knowledge of ICH and other global regulatory guidelines.
    • In-depth expertise in at least one regulatory specialty area: preclinical, clinical, CMC, publishing, etc.
    • Strong understanding of budgeting and forecasting, with keen attention to detail and strong analytical skills.
    • Capable of supervising, evaluating, and mentoring departmental personnel, and facilitating task completion.
    • Ability to drive innovation and develop new ideas for process improvements.
    • Strong organizational, judgment, analytical, decision-making, and interpersonal skills to manage complex projects and adapt to rapidly changing priorities.
    • Proficient in Microsoft Word, Excel, Adobe Acrobat, and other relevant software.
    • Capable of independently assessing sponsor needs and collaborating with project team members to produce compliant deliverables.
    • Able to learn new technologies independently.

    Join us in our mission to provide exceptional regulatory guidance and support innovative product development. Apply today to become part of our dedicated team.

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