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Senior Director, Regulatory Affairs, Late Stage - Remote USA

Company: POINT Biopharma
Location: Miami
Posted on: January 16, 2022

Job Description:

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. Currently, our employees are working remotely and located within the Eastern Time Zone. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.

Reporting to EVP of Regulatory Affairs, the Senior Director will oversee and direct all regulatory activities for new products to ensure alignment and compliance with local and regional registration requirements as well as with company policies.

Objectives

  • Develop and implement strategies for timely submission and approval of applications for late stage clinical trials, marketing applications.
  • Provide counsel pertaining to regulatory matters
  • Ensure timely preparation of organized and scientifically valid applications.
  • Provide expertise in translating regulatory requirements into practical, workable plans.
  • Interact directly with regulatory agencies.
  • Support efforts to select, develop and evaluates Personnel to ensure the efficient operation of the function.

    Accountabilities
    • Accountable for leading and implementing the regulatory and filing strategy for assigned POINT products in late phase development
    • Ensure that the strategy is designed to deliver approval in keeping with the properties of the products and the needs identified by business, markets, and patients. This includes health authority engagement strategy and considerations of expedited regulatory programs
    • Set the strategy with the EVP of Regulatory and planning for the interaction, driving formulation of briefing documents
    • Lead the team through meeting rehearsals
    • Deliver on regulatory milestones including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations
    • Lead preparation of the regulatory strategy document
    • Accountable for initiating and delivering key regulatory documents and plans
    • Lead the objective assessment of emerging data against aspirations and update senior management on project risks
    • Work cross-functionally to identify, develop and prioritize life cycle management strategies
    • Closely follow evolving regulatory environment and initiatives (e.g. FDA OCE) to identify and apply to our programs, accelerate registration and increase awareness of the potential for radiopharmaceuticals in Oncology

      Requirements
      • BSc, Masters Degree, Pharm D or equivalent scientific degree (biology, chemistry)
      • At least 10-year experience in the pharmaceutical industry, drug regulatory authority or industry trade association, of which 7 years in a regulatory affairs or regulatory policy and intelligence position. Oncology experience is highly desirable.
      • Proven experience with communications and preparing teams for interactions with FDA Health Canada and other regulatory agencies
      • Demonstrated experience with the planning, organization and conduct formal meetings with regulatory agencies
      • Key contact for personnel in regulatory agencies or country representatives to ensure understanding of requirements, timelines and the expedited resolution of issues, leading to timely approval of applications
      • Familiarity with the functioning of the European institutions
      • Experience in drafting position papers/memos, leading cross-functional teams and giving public presentations
      • Professional fluency in English
      • Relevant computer literacy skills
      • Good understanding of guiding principles in drug development such as benefit and risk profile, dose, selection or statistical design
      • Ability to work strategically within a complex, business critical development program
      • Experience working with CRO/Consultants

        Why joining POINT today will be the right career move for you:

        There is no shortage of demand for smart, qualified and hardworking people like yourself - and we strongly believe POINT is the right career move for you. Here is why:
        • You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
        • You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
        • You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
        • Most importantly, you will spend everyday working on something important

          If what we are saying resonates with you, please submit a cover letter and resume.

          Benefits
          • Health Care Plan (Medical, Dental & Vision)
          • Retirement Plan (401k, IRA)
          • Life Insurance (Basic, Voluntary & AD&D)
          • Paid Time Off (Vacation, Sick & Public Holidays)

            All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

            POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Keywords: POINT Biopharma, Miami , Senior Director, Regulatory Affairs, Late Stage - Remote USA, Executive , Miami, Florida

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