Director, Global Regulatory Affairs, Oncology Precision Medicine

Title:

Director, Global Regulatory Affairs, Oncology Precision Medicine

Company:

Ipsen Innovation (SAS)

Job Description:

Job Title:  

Director, Global Regulatory Affairs, Oncology Precision Medicine

Division / Function: 

Research & Development, Global Regulatory Affairs (GRA)

Manager’s Job Title: 

VP, Global Regulatory Affairs, Oncology

Ipsen Job Profile:

Regulatory TA

Location:

London (Paddington) or Paris (Balard)

WHAT - Summary & Purpose of the Position

We are seeking a highly skilled and experienced Regulatory Affairs strategist to join our team. The successful candidate will specialize in the development and registration of medical devices and particularly in vitro diagnostics (IVDs). This role involves providing strategic advice to the R&D organisation on optimal regulatory pathways that ensure compliance with regulatory requirements relating particularly to the development and use of In Vitro Diagnostic and companion diagnostic products and more generally to medical devices. A strong set of technical and soft skills is required to enable success in this role. The task of this role also includes seamless interaction with medical device/IVD developer partner companies as well as a broad scope of cross functional internal stakeholders to secure alignment on strategy. The role will also secure the appropriate and timely execution of the medical device regulatory strategies including the preparation and submission of regulatory documentations and liaising with regulatory authorities as appropriate.

WHAT - Main Responsibilities & Technical Competencies

• Responsible to provide strategic regulatory expertise, development and procedural advice to support decisions on development and registration strategies across Ipsen’s product portfolio involving medical device and in vitro diagnostic, including support to the interpretation and application of relevant regulatory requirements

• Provide strategic guidance on the development of biomarkers, diagnostic tests, and digital health tools.
• Drive preparation and submission of regulatory documentation, including pre-market submissions, technical files, and design dossiers and liaise with regulatory authorities and notified bodies to support product approvals.

• Lead the successful interaction and negotiation with partner companies that provide device/IVD support or supply.

• Drive alignment with the global regulatory leads in the interface with the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities for medical devices and IVDs.

• Collaborate with cross-functional teams to integrate drug and diagnostic regulatory plans, including health authority engagement and mitigation strategies into overall drug R&D plan.

• Develop and maintain an overall regulatory roadmap and the relevant procedure for the management of medical devices and IVDs

• Lead developing and enhancing a company-wide cross functional process that supports the timely and successful development of IVDs and Devices.

• Ensure Regulatory Intelligence for the IVD and Device regulations in key markets and perform impact assessment and communicate the implication of upcoming trends that may impact the business.

• Responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities or trade associations dealing with IVD and medical devices,

• Ensure compliance with global regulatory requirements and proactively identify and manage regulatory risks.

• Act as a mentor and coach to regulatory affairs team members to foster professional growth and development.

Global Perspective

• Considers both long- and short-term perspective, looks for/ understands blind spots and ambiguity
• Sees the bigger picture/thinks holistically (e.g. markets, future trends, Ipsen's strategy)
• Able to show environment/ society shaping capabilities

Manage Complexity

• Identifies contradictory information/demands/inputs to effectively solve problems
• Develops and evaluates alternative scenario and solutions
• Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact

Influences

• Listens and observes actively (paraphrases, summarizes, uses body language) and reflects on what was said, builds on what others are saying
• Gets insights on objectives of other stakeholders and is able to identify common interests
• Actively seeks "win-win" partnerships/solutions
• Able to embark internal and/or external stakeholders without hierarchical relationships

Communicates Effectively

• Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and non-verbally) and able to relate to other points of view
• Communicates transparently, "tells it how it is" while keeping the communication respectful
• Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Extensive industry experience (minimum of 10 years) mostly in the area of development and registration of medical devices and IVDs with strong regulatory affairs background covering both Europe and the US.
• In-depth knowledge of international regulatory requirements and guidelines relevant to IVDs and MDs (e.g., FDA/CDRH, EMA, ISO 13485, IVDR, etc).
• Proven track record of hands-on experience in the medical device and/or IVD industry with successful registrations of products.
• Strong analytical and problem-solving skills.
• Excellent leadership, written and verbal communication, and interpersonal skills.
• Ability to work independently and as part of a team.
• Detail-oriented with strong organizational skills.

Education / Certifications (essential):

• Advanced degree in life sciences, pharmacy, or a related field discipline (e.g., Biology, Chemistry, Biomedical Engineering)

Language(s) (essential):

• Excellent written and spoken English is required.

Hybrid model (60% on site/40% teleworking)

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.