Regulatory Affairs Officer - FTC - 1YEAR

 WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

As an employee of KKI, you already know that everything we do here is rooted in the idea of leaping forward to make people smile(e)We’re committed to innovation, for the benefit of the patients who count on us to support them(e)Our team is proud of all we deliver, but also humble in knowing how much more needs to be done(e)As you hear patient stories, you gain better insight of the obstacles patients and their families’ face – so we can collectively work together to better meet their unique needs(e)The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their wellbeing through our work(e)While the journey is not easy, it is one that is filled with purpose(e)And we want you to continue on this path with us.

JOB PURPOSE:

In collaboration with the Regulatory Affairs Manager, carry out all activities related to the registration and maintenance of marketing authorizations (MA) in compliance with regulations and in accordance with Group directives within the company.

Participate in meetings and project groups with the international in collaboration with the Group's policy.

RESPONSIBILITIES:

• Advise and assist the departments within the subsidiary (Quality Assurance, Marketing, Medical, Management, Business Division, etc.) on all regulatory matters ;
• Controlling the regulatory compliance of advertising (promotional, environmental and institutional documents) and the submission of files in conjunction with the Pharmaceutical Affairs Assistant, followed up with the ANSM if necessary;
• Preparing specific regulatory applications (applications for clinical trial authorization, temporary authorization for use (ATU), import applications, etc.) ;
• Coordinate the preparation of Marketing Authorization (MA) and post-MA files in transparency with the EMEA group and/or MA holders;

• Analyze the regulatory variations made by the EMEA group for products for which they hold marketing authorizations;
• Follow up on MA applications and participate in the drafting of answers to questions from the competent authorities by collecting the necessary additional information; Follow up and/or control post-MA dossiers (renewals, variations, etc.); Control variation dossiers and MA dossiers; Manage databases and archives of MA dossiers and regulatory information; Draft administrative and/or pharmaceutical observations of MA variations for the product(s);
• Participate in the management of registered or cohort ATU products.
• Elaborating, validating and distributing texts relating to packaging articles, product information and official documents, including the updating of legal notices; Drafting or updating the procedures inherent to the regulatory activity;
• Actively participate in the Quality Management System in a continuous improvement process.

All activities are implemented within the framework of pharmaceutical regulations, strategy and the company's quality policy(e)Adheres to the promotional information charter and applies it according to the terms of the certification reference framework in force(e)Applies Kyowa Kirin's processes which take into account the regulations in force (promotional information charter, advertising, law governing benefits, transparency, pharmacovigilance, RGPD, etc.).

QUALIFICATIONS:

• Pharmacist doctor registered with the order.
• Knowledge of pharmaceutical business, legislation, regulations and authorities at the national level.
• Experience in Regulatory Affairs, knowledge of the French market and French regulations (minimum 3 years).
• Successful experience of working with cross-functional teams at local and international level.
• Operational English required.

Acting as a role model for others, while respecting Kyowa Kirin's culture and values.

Key Competencies specific to the role: 

• Kyowa Kirin's core competencies: results-oriented spirit, sense of urgency and operational excellence.

Strong adherence to Kyowa Kirin's values (Commitment to life).

BENEFITS:

In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development(e)Plus:

• Competitive salary
• Bonus
• Pension scheme
• Private medical insurance

 

We’d love for you to keep growing within our organization by offering your unique ideas and diverse approaches to any obstacles that lie ahead(e)More importantly, we want you to fulfil our ultimate goal of making people smile.

kyowakirin.greenhouse.io/internal_job_board

Kyowa Kirin International is an equal opportunities employer.