The Director of Regulatory Affairs will be a key member of iTeos Therapeutics’ Leadership Team and be responsible for developing iTeos Therapeutics’ global regulatory strategy, represent iTeos in regulatory interactions and ensure execution of regulatory requirements and provide input into internal quality systems. This role requires expert interpretation of requirements relating to the development and licensing of cancer therapeutics and communication to cross-functional teams to create innovative regulatory strategies for targeted small molecules and biologics to treat cancer. This position will report to the Chief Medical Officer and will have extensive interface with the senior management team.
- Responsible for developing innovative global regulatory strategies and working with the cross-functional project team on execution.
- Leads interactions with global regulatory agencies
- Represents regulatory affairs in the leadership team and on cross-functional project teams to provide regulatory guidance and education through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements.
- Provides oversight for regulatory staff (whether at CRO or internally) and assesses and makes recommendations on staffing requirements.
- Develops and manages regulatory submissions and related supplements and amendments with the support of a CRO.
- Responsible for developing and maintaining regulatory strategy documents.
- Interacts directly with health authorities and maintains excellent relationship with regulatory personnel.
- Works with the team to integrate biomarker/companion diagnostic strategies into the development of assigned programs.
- Educates company on regulatory requirements and evolving trends and disseminates regulatory policy and intelligence relevant to the business.
- Provides regulatory due diligence assessments of new business opportunities.
- Advanced degree in a scientific or health-related field
- Seasoned professional with at least 5 years of regulatory affairs experience in the biopharmaceutical industry
- Exceptional communication and presentation skills to articulate complex regulatory strategy and decision-making both internally and externally
- Experience and comfort with pushing the boundaries and asking challenging questions both of the internal team and of the regulatory authorities.
- Experience in providing strategic advice on integrated regulatory development plans and executing regulatory strategy for cancer therapeutics.
- In-depth working knowledge of regulations, guidance, policies, and procedures pertinent to drug and biologics development and operational knowledge of IND/CTA and NDA/BLA/MAA submissions.
- Experience with development of biomarkers and IVD companion diagnostics devices preferred.
- Exceptional writing skills with experience in drafting and submitting timely drug and biologic applications to health authorities.
- Track record of building an excellent relationship with the FDA, EMA and other regulatory agencies.
- Quality mindset.
- Entrepreneurial, resourceful, energetic, self-starter
- Approaches challenges with creativity and pragmatism
- Ability to engage team to achieve goals without direct authority
For our recruitments in Belgium, we closely collaborate with a Recruitment & Selection company, PaHRtners. Your application will be automatically forwarded to them. We, together with PaHRtners, will keep all your data confidential (GDPR compliant approach).