Senior Global Regulatory Affairs Manager

Ferring Pharmaceuticals

Kastrup, Denmark

Your day at Ferring

You will collaborate with specialists from various disciplines, including colleagues from sister teams in Global Regulatory Affairs as well as Global Pharmaceutical R&D, manufacturing sites, Product Supply, affiliates, and development sites worldwide.

Most of your time will be spent contributing to a cross-functional team, representing regulatory CMC, working alongside highly skilled and equally dedicated colleagues.

Drawing on your experience with advanced therapy medicinal products, you will:

Act as a senior regulatory CMC representative and responsible for the regulatory CMC aspects of regulatory submissions and approvals for worldwide market expansions and approvals;
Provide regulatory CMC strategy and expertise to cross-functional teams such as our global regulatory project teams, CMC teams, product teams, and launch teams;
Represent Global Regulatory Affairs in the due diligence process and provide GRA CMC input;
Perform regulatory impact assessments of CMC changes for development projects and established products and drug substances, and ensure that adequate; documentation is timely generated, submitted, and approved worldwide;
Drive and execute authority interactions with national Competent Authorities concerning CMC activities;
Participate actively in the development and optimization of departmental and working processes.

Behind our innovation - there’s you

You bring a proactive mindset and a desire to find innovative solutions to regulatory challenges, which could be tied to, e.g., the submission of the first MA or interacting with health authorities.

To be able to do so, we imagine that you have extensive experience with global regulatory affairs CMC.

More specifically, we are looking for:

More than 8 years of solid experience in Global Regulatory Affairs CMC focusing on advanced therapy products/biologicals;
Experience in facilitation of risk management discussions;
A degree as M.Sc. in life science or pharmacy.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job