Senior Manager/ Associate Director, Regulatory

On-site presence in the South of France once per month for 2-3 days.

Stirling Q&R, a leading recruitment company, is currently assisting our esteemed client in the search for a highly experienced Senior Manager/Associate Director, Regulatory Affairs. Our client, a renowned global biotech company specializing in oncology, is dedicated to improving treatment and clinical outcomes for patients through the development of therapeutic antibodies that harness the immune system to fight cancer.

**Job Duties**: As the Senior Manager/Associate Director of Regulatory Affairs, you will be responsible for a range of key duties, including:

- Regulatory Strategy Development: Defining and implementing successful global regulatory strategies (FDA, EMA, etc.) for assigned projects.
- Operational Regulatory Planning: Developing and executing operational regulatory plans aligned with the defined strategies.
- Submission Leadership: Leading the submission task force to support regulatory submissions and interactions for assigned projects. This includes planning, preparation (including authoring, where relevant), and delivering regulatory submissions.
- CRO Management: Managing regulatory contract research organizations (CROs) for coordination and preparation of submissions.
- Cross-Functional Collaboration: Working with cross-functional teams to define their contributions to submissions and leading regulatory activities for assigned projects.
- Regulatory Knowledge Development: Maintaining and developing knowledge of the global competitive landscape, regulatory environment, and regulations.

**Requirements**:

- University degree in biomedical sciences (BS/MS/Pharm) or a related field
- Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry
- Proven track record in developing successful regulatory strategies
- Hands-on experience in preparing successful regulatory submissions in oncology, including CTAs/INDs, MAA/BLA, and interactions with competent authorities in the EU and/or USA
- Ability to lead and provide regulatory input to cross-functional project teams

**Background and Experience**:

- Extensive experience in regulatory affairs within the pharmaceutical industry
- Demonstrated success in developing and implementing regulatory strategies
- Strong knowledge of regulatory submissions in oncology, including CTAs/INDs, MAA/BLA, and interactions with competent authorities in the EU and/or USA
- Proven ability to lead and collaborate with cross-functional project teams
- Familiarity with global regulatory guidelines, including FDA and EMA regulations
- Excellent written and verbal communication skills, with the ability to communicate effectively at all levels within the organization
- Detail-oriented with strong organizational and analytical skills
- Ability to work independently and within a matrixed team structure
- Fluency in English is essential, and French language skills are advantageous

This is an exciting opportunity to join a global biotech company at the forefront of oncology research and contribute to improving patient outcomes. If you meet the requirements and have the necessary background and experience, we encourage you to apply.

+44 1293 307201

Type d'emploi : Temps plein, CDI

Salaire : 72 000,00€ à 120 000,00€ par an

Avantages:

- Travail à domicile

Exigences linguistiques flexibles:

- Français non requis

Programmation:

- Du lundi au vendredi

Types de primes et de gratifications:

- Prime annuelle

Capacité à faire le trajet ou à déménager:

- Paris (75): Faire le trajet sans problème ou déménager avec l'aide de l'employeur grâce au kit de relocalisation (Optionnel)

Question(s) de présélection:

- How many years of experience do you have with submissions such as INDs, CTAs, MAAs, BLAs?

Expérience:

- Regulatory Affairs: 7 ans (Optionnel)
- Oncology: 4 ans (Optionnel)

Lieu du poste : Télétravail hybride (Paris (75))