description du poste

1. Mission

The Head of Regulatory Affairs is a key member of the Senior Executive Team. As such, he/she provides regulatory strategy to the Chief Executive Officer and takes strategic and operational responsibility for leading global regulatory affairs matters relating to company objectives and programs.

As a member of the Senior Executive Team, he/she collaborates in establishing governance processes of direction and control to ensure that objectives are achieved, risks are managed appropriately, and the organization’s resources are used responsibly.

2. Responsibilities

Regulatory Strategy Development:

• Develop and implement global regulatory strategies for Novadip products, covering clinical, nonclinical, and CMC aspects.
• Identify potential risks associated with proposed strategies and develop mitigation plans.

Regulatory Compliance:

• Ensure that all required regulatory processes and instructions are in place and comply with relevant global regulatory requirements.
• Collaborate with QA to ensure that all products meet regulatory requirements and quality standards. This includes compliance with GxP and other relevant guidelines.
• Together with QA, manage any changes in manufacturing processes, equipment, or facilities. QA ensures that changes are validated and documented, while RA assesses the regulatory impact and submits necessary updates to regulatory authorities.
• Stay informed about changes in regulations and assess their impact on Novadip’s research and development programs.

Regulatory Submissions:

• Prepare and submit regulatory documents, including product applications and reports to regulatory agencies.
• Lead meetings and preparations with regulatory bodies like the EMA, FDA to facilitate expedited approval of applications.

Cross-functional Collaboration:

• Partner with Clinical teams on clinical trial design and pre-market approvals.
• Work with manufacturing teams on process and labeling, and with sales and marketing teams on product positioning and marketing claims.
• Collaborate with QA on risk assessments to identify potential quality and regulatory risks.
• Active participation in Project Team Meetings.

Regulatory Expertise and Guidance:

• Provide regulatory expertise for new strategic areas and technologies during early development.
• Offer advice and guidance to project teams and SME on the interpretation and application of relevant regulatory requirements.

3. Profile

• Min 15 Years experience in leading regulatory projects in pharma companies.
• Academic background related to the requirements of the position (BS/BA in Regulatory Affairs or Life Sciences. A Ms or a Ph.D. are a plus).
• Strong knowledge of Regulatory Sciences in ATMP’S, ideally, or in biologics / vaccines / medicinal products.
• Experience in face-to-face meetings with competent regulatory authorities (FDA, EMA).
• Excellent English verbal and written communication skills to articulate regulatory requirements clearly to various stakeholders, including regulatory agencies, internal teams, and external partners.
• The ability to write clear, concise, and accurate regulatory documents, reports, and submissions is crucial. This includes understanding and using appropriate regulatory terminology.
• Strong analytical skills to interpret complex regulations and assess their implications on the company’s products and processes.
• The ability to think critically and make informed decisions based on regulatory guidelines and scientific data.
• Building and maintaining strong relationships with regulatory bodies, internal teams, and other stakeholders is essential. This includes active listening, empathy, and conflict resolution.
• Ability to creatively and efficiently resolve unexpected issues with regulatory submissions or compliance strategies.
• Effective project management skills help in coordinating regulatory activities, ensuring timelines are met, and resources are efficiently utilized. This includes managing and aligning external consultants.
• The context of a biotechnology company and the regulatory environment are constantly evolving, so being adaptable and open to change is important.