Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.
Overall Objectives and Missions of the role
In the Clinical & Medical Affairs division within the Regulatory Affairs department, reporting to the Head of Regulatory Affairs, you will work within a matrix organization. You will be actively involved in the development of Innate’s immuno-oncology products through approval, responsible for the development and implementation of regulatory strategies and operational plans.
Within the Regulatory Affairs (RA) team, your main mission and responsibilities are the following:
- Definition and Implementation of successful global (FDA, EMA, etc.) RA strategies for assigned projects
- Definition and execution of operational regulatory plans aligned to the defined strategies
- Leading the submission task force supporting regulatory submissions/interactions for assigned projects, as well as the planning, preparation (including authoring where relevant) and delivering of the regulatory submissions
- Managing the regulatory CROs for coordination and preparation of submissions
Various Activities RA
- Assisting the Head of Regulatory Affairs in the various activities, including but not limited to, clinical trial applications INDs/CTAs, pediatric investigation plans, briefing documents, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation etc.
- Work with functional groups to define their contributions to submissions and lead regulatory activities for projects assigned
- Maintaining/developing knowledge of global competitive landscape, regulatory environment, and regulations
Experience and Qualifications
- A university degree in biomedical sciences (BS/ MS/ Pharm)
- Minimum BAC + 5, and equivalent of 7 years’ pharma industry experience in regulatory affairs
- Experience in preparation of successful regulatory strategies
- Hands-on experience in preparation of successful oncology regulatory submissions in EU and/or USA, e.g., CTAs/INDs, MAA/BLA, and interactions with the competent authorities
- Experience in leading and providing regulatory input to cross functional project teams
Competencies, Skills and Behaviours
- Knowledge of the clinical development of oncology products, as well as a working knowledge of fast-track approval processes and an innovative approach to regulatory submissions
- Understanding of the Good Clinical Practice regulations, ICH guidelines, Clinical Trial Regulation and internal SOPs
- Knowledge and understanding of biologics (mAbs) compounds is highly desired
- Strong software and computer skills, including MS Office applications and project management and analytical skills
- Ability to work independently as well as in a team matrix organization with little or no supervision
- Excellent written and verbal communication skills, ability to communicate effectively and confidently at all levels within the organization
- Able to remain motivated and enthusiastic in times of change and other pressure situations
- Ability to manage competing priorities, as appropriate
- Ability to exercise sound and independent judgement taking calculated risks when making decisions
- Detail oriented
- Demonstrate ability to navigate in an evolving environment
- Negotiating and influencing skills and the ability to identify and resolve issues, using flexible and adaptable approaches
- Remains calm, assertive and diplomatic in challenging interactions with internal/ external stakeholders
- The applicant must be able to read, write and speak English (French is an advantage)
NB: This job description is designed to describe a series of main tasks that may be encountered. It is not intended to be an exhaustive list of tasks and may be modified in consultation with the incumbent to reflect changes in the position or organization.
Innate Pharma believes in equal opportunities and welcomes all qualified applicants for employment without discrimination.