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Job

Senior Manager Regulatory Affairs

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Fahd Joudi

  • Contact email:

    f.joudi@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2022-12-05

  • Startdate:

    ASAP

The Senior Manager is responsible for the development, execution, and communication of regulatory strategies for investigational drug candidate(s) in line with the goals of the rheumatology and gastroenterology disease area(s) within the Inflammation therapeutic area and provides regulatory guidance. The SM will represent regulatory affairs on cross-functional development program and/or other teams as appropriate. The role reports to the Senior Director, Global Regulatory Strategy Leader for the Rheumatology and Gastroenterology disease areas within the Inflammation therapeutic area.   

Key Responsibilities:

  • Global and/or US/regional regulatory lead

  • Responsible for developing, executing, and communicating regulatory strategies in line with goals of Inflammation therapeutic area  

  • Responsible for preparing and submitting regulatory documents in line with ICH requirements, regional requirements, and scientific and company policies and procedures

  • Represent regulatory affairs and participate on cross-functional development program and/or other teams, including sub-teams (regulatory, study management, clinical, and/or biomarkers)

  • Lead contact with local Regulatory Authorities, based on responsibilities and as appropriate

  • Maintains up-to-date knowledge of regulatory requirements, contributes to preparation of new regulatory guidance where appropriate, and communicates changes in regulatory information

  • Initiates or contributes to local and/or global process improvements which have a significant impact on business

Minimum Qualifications:

  • 8+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA or 6+ years of experience with advanced science degree (PhD, PharmD, MD, MSc)

  • Experience as regional regulatory lead managing investigational and marketed products and representing Regulatory Affairs on cross-functional teams

  • Ability to act as primary Company contact with Regulatory Authorities

  • Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements and understand current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business

  • Must be capable of developing and implementing regulatory strategies and of managing negotiations with regulatory authorities

  • Must be capable of reviewing technical documents and influencing colleagues across functions

  • Must be capable of effectively leading teams in preparation of submissions

  • Excellent organizational skills and ability to work on several projects under tight timelines

  • Excellent verbal and written communication skills and interpersonal skills required

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