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    Senior Manager (Level 1)

    Pharmalex
    3+ years
    Not Disclosed
    Mumbai
    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 Senior Manager (Level 1), you will play a crucial role in our regulatory affairs team, focusing on the following responsibilities:

    • Strategic Collaboration: Work closely with the VDC to design and implement coordinated service strategies.
    • Regulatory Affairs Services: Provide a comprehensive range of regulatory affairs services for various clients across different product types and therapeutic areas.
    • CMC Leadership: Offer expert leadership and support for Chemistry, Manufacturing, and Controls (CMC) activities, including project management, gap analysis, and strategy development.
    • Documentation Review: Conduct quality control reviews of documentation, ensuring compliance through compendial cross-checking and proper report formatting.
    • Technical Review: Perform critical technical reviews of documentation based on extensive experience in the field.
    • Consulting Support: Provide consulting services for CMC-related activities.
    • Team Management: Act as the line manager for assigned staff, overseeing their development and performance.
    • Project Coordination: Manage project coordination and resource allocation effectively to meet client needs.

    Your Profile:

    • Work Ethic: Autonomous, focused, and dedicated to delivering high-quality work.
    • Team Collaboration: Ability to work collaboratively within a team environment.
    • Responsibility: Strong sense of responsibility and accountability.
    • Language Proficiency: Excellent command of English, both written and verbal.
    • Educational Background: Graduate, Post-graduate, or Doctorate degree in life sciences, Pharmacy, Medical sciences, or a related field.
    • Experience: 5-8 years of relevant experience in regulatory affairs or the biotech industry.
    • Attention to Detail: Well-organized with a keen attention to detail, ensuring accuracy and a right-first-time approach.
    • High Standards: Consistently deliver at a high standard while striving to exceed expectations.
    • Client Communication: Excellent communication skills with a strong focus on client-facing interactions.
    • Regulatory Experience: Established experience in regulatory activities, including Module 3 IND/IMPD authoring and review, MAA/BLA gap analysis, and regulatory strategy.
    • Product Knowledge: Proven experience with a variety of biotech product types, including ATMPs, vaccines, recombinant proteins, and biosimilars.

    If you are excited about taking on this challenging role within our innovative team, we look forward to receiving your application!

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