Responsable Affaires Réglementaires Bu Cdmo - Lyon, France - Axplora

Axplora

Entreprise vérifiée

Lyon, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

Axplora's mission is to be a trusted manufacturing partner to the world's leading pharmaceutical and biotechnology companies.

Driven by passion, curiosity, and dedication of our highly skilled employees, we aim to make them being proud to collaborate with our customers to deliver cutting-edge products for the benefit of humankind.

While accomplishing our vision of providing API for medicines on time and at scale, we offer a caring and safe environment in which our people can leverage their full potential.

Our 2.500 employees are based in Europe, India and the USA, and Axplora is organized in 3 BUs (CDMO services, Specialty products, Steroids & HPAPI products).

BU CDMO is gathering more than 1000 employees based in 7 sites located in Europe and USA. It is a leading player in fast-growing CDMO market (ADC, Omega3 ) with technology-driven differentiation such as chromatography, hazardous chemistry, cryogeny and flow chemistry

We are looking for a Regulatory Affairs Team Manager (M/F) as a permanent contract.

Reporting to the Global Head Of Regulatory Affairs, your main tasks will be:

your tasks and responsibilities
Lead the RA team for the business unit CDMO

Manage client files directly in addition to supervising the team

Regulatory focal point and advisor for business unit CDMO management team

Report to the global head of RA

Provide mentoring and technical support to RA team CDMO

Develop and implement registration strategies for active pharmaceutical ingredients in alignment with marketing goals and customer's expectations

Preparation, submission, maintenance and review of regulatory filings for worldwide registration of active pharmaceutical ingredients (DMFs/ASMFs, CEPs, IMPDs, Module 3)

Evaluation and coordination of changes and preparation of variations to registration documents

Monitoring of regulatory legislation and guidelines

Provide current regulatory information and guidance to other departments

Participate in cross-functional team meetings as a regulatory representative

Regulatory affairs contact person for health authorities and customers

Qualifications:

University degree in chemistry, biology or pharmacy
5/10 years professional experience in regulatory affairs for APIs
Excellent knowledge of applicable regulatory affairs laws, regulations and policies
General understanding of compliance issues confronting the pharmaceutical and API industry
General understanding of GMP requirements
Fluent in English
Verry good MS Office skills
Knowledge in eCTD submission tools (e.g. Docubridge) is an advantage
Demonstrated effectiveness operating in complex organizational and regulatory environments
Excellent written and oral presentation skills
Proven ability to work with all levels of management and the general workforce
Excellent human relations, creativity, negotiation, analytical, decisionmaking and problemsolving skills
Proper project management skills