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Director Regulatory Affairs

1 month ago

ma united states Jobleads-US Full time
Director Regulatory Affairs - Watertown, MA (US)

iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies.

Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UClouvain) in 2011. As a science-driven company with a robust pipeline, we have successfully completed multiple funding rounds, including a transformative $2.145 billion co-development and co-commercialization agreement with GSK for our anti-TIGIT monoclonal antibody, EOS-448.

As we continue to evolve as a world-class leader in immuno-oncology, we seek highly innovative, proactive, and strategic thinkers to advance our portfolio and lead clinical development efforts. We offer a collaborative, forward-thinking environment where team members are empowered to make significant contributions toward advancing therapies that have the potential to change the standard of cancer care.

Our values - Data Driven, Ownership, Courage, and Stronger Together - form the foundation of who we are as a company and define who we are at our core.

iTeos Therapeutics is now a world-class actor in the sector. To carry on its growth and reinforce its team, iTeos Therapeutics is looking for a Director Regulatory Affairs.

ROLE: Director Regulatory Affairs

The Regulatory Affairs professional helps to develop regulatory strategies and manage regulatory submissions in the US.

You will report to the Vice President of Regulatory Affairs and will work in a cross-functional matrix structure with other R&D functions.

MAIN RESPONSIBILITIES

  • Provide US regulatory support for all iTeos products.
  • Serve as global and US regulatory lead for programs in clinical development.
  • Advise on regulatory strategies and operational plans from US perspective (act as the US regulatory expert).
  • Coordinate all aspects of regulatory submissions, e.g.:
    • Develop and manage regulatory project timelines;
    • Provide regulatory guidance on requirements for IND filings;
    • Coordinate preparation and review of regulatory documentation (INDs, IMPDs, clinical protocols, annual reports, labelling materials, meeting materials, briefing books, fast track and orphan drug designations, paediatric study plans, proposals for investigator-initiated trials, responses to Agency's queries, etc.);
  • Work with the regulatory operations group for preparation and submission of health authority documents.
  • Serve as the primary interface with health authorities.
  • Participate as a regulatory representative at relevant teams advising on regulatory strategies, submission preparation timelines, processes and requirements.
  • Monitor and evaluate the US regulatory affairs environment. Maintain an awareness of current and future risks that may impact business.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

  • B.S. or MSc, degree within a scientific discipline required with 7+ years' experience in US Regulatory Affairs (Pharmaceutical or Biotechnology Industry).
  • All-rounder profile with specific experience in managing submissions encompassing all areas of regulatory affairs (CMC, Clinical, Non Clinical,…).
  • Oncology regulatory experience.
  • Highly detail-oriented with ability to interpret complex information via excellent written, presentation/oral communication, and customer service skills.
  • Effective collaborator who can bring together multiple stakeholders and able to build positive relationships, with both internal and external partners.
  • Change-Agility needed, a mindset who can thrive in a dynamic, complex, and regulated environment.
  • Based in Watertown, US.

LEADERSHIP CHARACTERISTICS

  • Approaches challenges with creativity and pragmatism. Ability to work in a fast-moving and challenging biotech environment.
  • Ability to engage teams to achieve goals without direct authority.
  • Driven to move the R&D programs forward at full speed while maintaining quality.

OFFER

  • A stimulating position within a high-potential innovative biotech company.
  • The opportunity to work in a science-driven, dynamic, respectful and professional environment.
  • A challenging scientific and business growth in which you get to bring your knowledge and skills.
  • An employment agreement contract with an attractive salary package in line with the position responsibilities and your experience.

RECRUITMENT PROCESS

Please send your CV together with an adapted cover letter to the following address: jobs@iteostherapeutics.com. Please mention the reference DRA in the mail object. Your application and related information will strictly confidential.

For this open vacancy in US, we closely collaborate with Hobson Prior (Recruitment & Selection company). Your application will be automatically forwarded to them. We, together with Hobson Prior, will keep all your data confidential (GDPR compliant approach).

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