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Senior Director of Regulatory Affairs - Remote

Company: Precision Medicine Group
Location: Bethesda
Posted on: May 12, 2024

Job Description:

Senior Director of Regulatory Affairs - Remote
at Precision Medicine Group (View all jobs)
Frederick, MD, USA

Are you looking for an opportunity where you can use your expertise to provide strategic, technical, and regulatory guidance for clinical development and drug development life cycles? A role where you can lead regulatory consulting services and maintain technical knowledge in product development and international regulatory affairs? If so, we're hiring a Senior Director of Regulatory Affairs!

About You:

  • You have 12+ years or more relevant regulatory affairs experience.
  • You possess a comprehensive understanding of financial management.
  • You have expertise in all aspects of the drug development process inclusive of regulatory milestones and clinical trials methodology, including a working knowledge of protocols and indications being studied.
  • You have specialized knowledge of regulatory activities including but not limited to submissions to regulatory authorities, including INDs/CTAs and
    amendments, ODDs, and PIPs.
  • You can understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.
  • You are experienced in pharmaceutical product development and marketing authorizations (MAA/CTAs/INDS/NDA and or BLA/sBLA) experience in filings in an eCTD format.
  • You are eager to develop, coach, and mentor regulatory team members, ensuring the sharing of best practices across the team.
    About the Role:

    As a Senior Director of Regulatory Affairs, you are responsible for the provision of high-quality regulatory technical advice and development strategies for clients across a wide range of therapeutic indications and will provide regulatory strategy and leadership for all North America and/or International (inc. European) regulatory submissions. You will lead and support teams and efforts around major filing activities and Health Authority interactions, and will provide regulatory support to other departments, project teams, and committees. In this leadership role, you will support the further development of the Regulatory department and enhance corporate Regulatory functions and facilitate business development and proposals in this area.

    Required:
    • Post Graduate Degree, bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline
    • Experience in functional management including experience in delegating while fostering cohesive team dynamics
    • Computer literacy in MS Office/ Office 365
    • Availability for domestic and international travel including overnight stays
      Who We Are

      Precision for Medicine is the first global, precision-medicine, clinical research organization. Purpose-built to shift the development curve for life sciences clients, we incorporate laboratory expertise, clinical trial excellence, and advanced data sciences at every stage. Known as Precision Convergence, this integrated approach enables us to deliver critical insights into patient biology from early development through approval. The result: More predictable trial outcomes. Accelerated clinical development. New life-changing treatments for the patients around the globe.

      Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

      Reasonable estimate of the current range

      $150,800 - $226,200 USD

      Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice .

      Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. - 2020 Precision Medicine Group, LLC

      If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .

Keywords: Precision Medicine Group, Bethesda , Senior Director of Regulatory Affairs - Remote, Executive , Bethesda, Maryland

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