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Job

Manager, Regulatory Affairs

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Antoinette Miller

  • Contact email:

    a.miller@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    3 months ago

  • Expiry date:

    2022-05-02

  • Startdate:

    ASAP

Dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments, as well as clinical programs in multiple therapeutic areas. We have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. 

About the Role:

Responsible for supporting regulatory strategy execution for development programs. Works closely with the Director of Regulatory Affairs to prepare regulatory submissions (strategy, authoring, timeline planning, etc.) and to maintain department regulatory processes. Coordinates, prepares, and contributes to the development of document packages for regulatory submissions including IND/CTA, NDA/BLA. DSUR/Annual Reports, clinical protocols, clinical study reports, application amendments and post approval activities. Ensures submission compliance with local and regional regulatory requirements, company policies, and internal quality and compliance standards. Provide regulatory representation on cross-functional teams as directed. Collaboratively develop regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs. Provide regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials. Perform regulatory research and communicate new/emerging regulations to management and project teams. You will be supporting our amazing products currently in our pipeline.

Your Contributions (include, but not limited to):

  • Develop, review and/or file INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring DSURs, annual reports, amendments as needed

  • Provide regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs

  • Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Company programs

  • Develop and manage project timelines for regulatory submissions

  • Lead, coordinate, author, critically review and provide strategic input on regulatory filing documents

  • Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, and clinical study recruitment materials

  • Conduct regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams

  • Develop and maintain standard operating procedures and department working practices

  • Ensures the company is adhering to all applicable government regulations

  • Complete assigned activities with the project team

  • Other duties as assigned

 

Requirements:

  • BS/BA degree in Life/Health Sciences and 8+ years of industry experience of which a minimum of 3 years must be Regulatory Affairs experience in drug development at a research-based pharmaceutical company, including two years in a lead capacity. Experience with FDA regulations and ICH guidelines for regulatory submissions OR

  • Master’s degree in Life/Health Sciences preferred and 6+ years of related experience OR

  • PharmD or PhD and 4+ years of related experience

  • Ability to work independently with minimal direction, including functional representation within project teams in order to attain group goals

  • Thorough understanding of FDA regulations and ICH guidelines for regulatory submissions

  • Demonstrated understanding of laws, regulations, standards, and guidance governing drug development (e.g., US regulatory knowledge) a plus

  • Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines

  • Works to improve tools and processes within functional area

  • Developing reputation inside the company as it relates to area of expertise

  • Ability to work as part of and lead multiple teams

  • Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams

  • Excellent computer skills

  • Excellent verbal and written communications, problem-solving, analytical thinking skills

  • Sees broader picture, impact on multiple departments/divisions

  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

  • Excellent project management skills

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