Responsible Pharmacist and RAPV Affiliate Team Lead France

Description
Responsible Pharmacist and RAPV Affiliate Team Lead France

About Astellas
At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity
As Responsible Pharmacist and RAPV Affiliate Team Lead France, you will lead Regulatory Affairs & Pharmacovigilance (RAPV) at local level with line management responsibility for the RAPV team. Also, you will represent Astellas towards local Health Authorities and pharmaceutical industry associations, where appropriate.

This position holds the legislative role of Pharmaceutical Affairs Director (Chief Pharmaceutical Officer) provided by article L of the French Public health Code i.e., Organize and supervise pharmaceutical operations: pharmaceutical monitoring (sales, shortage plan, recalls, distribution, batch traceability), importation and exportation, pharmacovigilance, medical information, promotion.

Hybrid Working
At Astellas, we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key Responsibilities

• Pharmacien Responsable responsibilities as defined in article R CSP).
• Represent Astellas towards local Health Authorities and pharmaceutical industry associations.
• Represent Pharmaceutical Affairs in the affiliate Management Team (MT).
• Represent France in the Established Markets RAPV Leadership Team (LT).
• Leadership and line-management for the RAPV team and Promotional Charter Associate.
• Identify and implement ways for RAPV to contribute to growth by defining priorities based on business opportunities and affiliate's business objectives.
• Align affiliate RAPV strategy and planning of activities with local Brand Teams, including relevant extended members.
• Support proper implementation of RAPV submission outcomes, including preparation of artworks (printed packaging components) and communication of Product Information to relevant stakeholders.
• Ensure that RAPV review and approval of (abbreviated) prescribing information and promotional materials is in accordance with Astellas standards and country legislation.
• Manage the affiliate RAPV budget in a cost-efficient manner.

Essential Knowledge & Experience

• Extensive management experience in Regulatory Affairs, Pharmacovigilance, or combined PV/RA/QA.
• Proven ability to develop and maintain effective relationships with external bodies.
• Proven ability to work in a cross-functional international matrix environment
• Fluent in spoken and written French and English.

Preferred Knowledge & Experience

• People management experience.

Education/Qualifications

• Recognised Pharmacy qualification + compliance with article R of the French Public Health Code.
• No impediment to be registered as Responsible Pharmacist as per criteria of article R of the French Public Health Code.

Additional Information

• This is a permanent full-time position.
• Location: This position is based in France.
• This position follows our hybrid working model. Role requires a blend of home and minimum 2 day per week in our respective local affiliate office in Levallois-Perret. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.

We Offer

• A challenging and diversified job in an international setting
• Opportunity and support to continuous development
• Inspiring work climate

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.

Levallois-Perret