Regulatory Affairs Expert

Role description

At LEO Pharma, we are on a transformative journey to solidify our position as a global leader in medical dermatology. 

In our regulatory affairs department you are empowered for visible impact and are guided by our winning behaviors of simplification, collaboration, and accountability to achieve our goals.

Your role

You will become the responsible for the management of regulatory affairs proposes by proposing, implementing and ensuring the implementation of a technical-regulatory strategy for the company in order to guarantee compliance with pharmaceutical regulations for the development, registration, and operation of products.

As a regulatory expert, you accompanies the product throughout all stages (R&D, clinical trials, registration, advertising, validation of packaging materials, waste management...).

Strategic definition of regulatory affairs :

•    Defining the regulatory strategic directions of the company based on current legislation.
•    Responsible for the establishment and monitoring of regulatory files.
•    Analysis and evaluation of risks related to the life cycle of the medicine/health product.
•    Development of registration strategies.
•    Coordination and planning of registration plans 
•    Implementation of systematic regulatory survey in France and Europe.
•    Particpation to the department's budget.

Intervention as an internal reference in their area of expertise :

•    Acting as an expert reference to the management and partners regarding the registration plan.
•    Providing support to the R&D department in identifying regulatory constraints during the feasibility phase.
•    Actively participating in the development teams of new medicines/health products and change control:
•  Reviewing technical reports.
•  Conducting regulatory assessments.
•  Drafting technical-regulatory documents, including risk management when necessary
•    Collaborating with relevant departments in the preparation and review of transparency and pricing/reimbursement files, and their submission to the authorities; in the discussions of contracts with HCP associations or patients associations

Coordination of relationships with health authorities and experts :

•    Managing professional relationships and interactions with health authorities for the registration and life cycle of medicines/health products.
•    Representing the company to health authorities.
•    Developing a network of external experts in the field of regulatory expertise related to lifecycle management of a product.
•    Speaking at conferences on regulatory affairs-related topics.

Advising on the communication strategy for promotional and non promotional activities :

•    Defining the regulatory strategy regarding the communication of medicines/health products in compliance with the code of promotional information.
•    Ensuring that communication strategies and all communication tools are in compliance with the Marketing Authorization (MA) and legislation on pharmaceutical advertising.

Project management:

•    Managing the work organization of regulatory affairs managers or other team members: project allocation, task definition, resource allocation, etc.
•    Selection and managing external partners.
 

Qualifications

To succeed in this role, we imagine that you have the following qualifications :

•    Doctor in pharmacy with 8 years of experience in a similar position

•    Knowledge of French (CSP) and European regulations for registrations.

•    Understanding the regulatory requirements of authorities regarding advertising, Charte of promotional information, anti-gift law

•    Knowledges with ANSM procedures and ability to identify the appropriate contact at ANSM.

•    Acting as a advisor/facilitator and being perceived as such by other departments within LEO France and the Group.

•    Simplifying and resolving regulatory problems, including being proactive in proposing solutions. 

•    Ability to research information to provide appropriate responses ; Intellectual curiosity, to assess the risk of situations and/or decisions, to explain and communicate the specificities of the French regulations to the parent company, to meet deadlines; Ability to provide appropriate and relevant responses.

•    Managing multiple cases simultaneously and handling cross-functional projects.

•    Proficiency in technical and administrative English.