Regulatory Affairs/Good Promotional Practices Manager

Regulatory Affairs /Good Promotional Practices Manager

at Kyowa Kirin International plc

France – La Défense

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

Provide regulatory leadership across promotional / non promotional activities and the product lifecycle.

Ensure compliance with regulatory requirements and internal standards.

Serve as Deputy Responsible Pharmacist when required.

Key Responsibilities:

· Lead regulatory activities across the product lifecycle, including early access, labelling, packaging .

• Ensure regulatory compliance of promotional and non-promotional materials, events, digital channels and media communications.
• Oversee promotional information activities , ensuring compliance with promotional information charter.
• Partner with Medical, Marketing and Commercial teams to embed regulatory best practice and drive continuous improvement.
• Manage relationships with health and regulatory authorities on product portfolio and promotional matters.
• Lead regulatory training and governance , ensuring teams have the knowledge, tools and guidance needed to operate compliantly.
• Monitor regulatory developments , assess business impact and coordinate appropriate action plans.
• Act as Deputy Responsible Pharmacist when required.

Position Requirements

• Pharmacist registered with the CNOP, with Deputy Responsible Pharmacist eligibility
• Experience in promotional material approval and early access coordination
• Strong knowledge of promotional information requirements
• 10+ years ’ pharmaceutical industry experience, ideally within an exploitant/manufacturing environment. (promotional material validation, MA management). Experience in a manufacturing environment is also preferred
• Pharmacist registered     as     a     deputy
• Responsible Pharmacist with the CNOP
• Fluent operational English.
• Analytical, adaptable and solution-focused, with strong teamwork and decision-making skills.

Compensation:

Salary range based on your experience between 75,000.0 Eur – 100,000.0 Eur / annum