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    Regulatory Affairs Consultant

    Parexel
    7-10 years
    Preferred by Comapny
    Bengaluru
    10 Nov. 25, 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 Consultant

    Job Description:

    The Regulatory Affairs Consultant will be responsible for managing the pre- and post-approval life cycle of drug products (both small molecules and biologics) in various global markets. With 7-10 years of relevant experience, the consultant will contribute to the planning, preparation, authoring, and delivery of regulatory maintenance submissions. This includes working on IND & IMPD submissions for the USFDA and EMA, managing biologics and biosimilars dossiers, preparing regulatory gap analyses, and defining regulatory strategies for product lifecycle management. The role also includes leadership in coordinating with stakeholders, ensuring compliance with regulatory guidelines, and mentoring team members.

    Key Responsibilities:

    1. Regulatory Submission Management:

      • Lead or contribute to the preparation, authoring, and submission of regulatory dossiers, including BLA/MAA submissions for US, EU, ROW, and India markets.
      • Author IND & IMPD submissions for biologics/biosimilars for USFDA and EMA.
      • Manage post-approval submissions for biosimilars, including annual reports, variations, and renewals (Europe Type IA/IB/II/IAIN).
      • Prepare and submit regulatory applications, including DMF, CTA, BMF, BLA, NDA, and MAA applications.

    2. Life Cycle Management (LCM):

      • Oversee the life cycle management of approved products, including annual reports, variations, and renewals.
      • Evaluate and define regulatory strategies for change controls, deviations, and product modifications.

    3. Regulatory Strategy & Gap Analysis:

      • Conduct regulatory gap analysis and develop strategy documents with remediation plans for IND, IMPD, BLA, NDA, and MAA applications.
      • Prepare scientific advice, briefing books, and Type 2 meeting packages for USFDA and EMA submissions.

    4. Stakeholder Coordination:

      • Coordinate with internal and external stakeholders to ensure the timely preparation and submission of required documentation.
      • Identify and resolve quality or timeliness issues with source documents as early as possible.

    5. Regulatory Knowledge & Compliance:

      • Maintain an up-to-date knowledge of global regulatory guidelines and their impact on submissions.
      • Apply regulatory requirements to ensure compliance and mitigate risks in the submission process.

    6. Regulatory Information Management:

      • Utilize Regulatory Information Management Systems (e.g., Veeva Vault) for document management and submission tracking.

    7. Team Mentorship & Leadership:

      • Provide guidance and mentorship to team members, fostering their professional development.
      • Collaborate with cross-functional teams to ensure alignment on regulatory strategies and submissions.

    8. PAREXEL-related Activities:

      • Meet established metrics as specified in the scorecard on an annual basis.
      • Complete basic job-related responsibilities, including timesheets, expense reports, training compliance, and project deliverable archiving.
      • Participate in internal initiatives and projects as requested by management.
      • Define self-development activities to stay current with industry trends and maintain membership in relevant industry associations.

    Skills and Experience:

    • Experience: 7-10 years of experience in regulatory affairs, specifically in managing the lifecycle of biologics and drug products.
    • Regulatory Knowledge: Strong understanding of global regulatory frameworks and experience with submissions such as IND, IMPD, BLA, MAA, NDA, and variations.
    • Submission Expertise: Experience in authoring and managing complex regulatory documents and dossiers.
    • Life Cycle Management: Expertise in managing life cycle activities for approved products, including change control and post-approval submissions.
    • Communication & Leadership: Excellent interpersonal and intercultural communication skills; ability to mentor and guide team members effectively.
    • Systems Proficiency: Familiarity with Regulatory Information Management Systems such as Veeva Vault.
    • Client-Focused Approach: Ability to manage client relationships and maintain focus on client needs and project deliverables.

    Education:

    • A degree in Life Sciences, Pharmacy, or a related field is required. An advanced degree (e.g., MSc, PhD) would be an advantage.

    Additional Requirements:

    • Strong project management knowledge and results orientation.
    • Critical thinking and problem-solving skills.
    • Fluency in English and proficiency in local languages is essential.

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