(Senior) Global Regulatory Affairs Manager - CMC

Ferring Pharmaceuticals

Kastrup, Denmark

Job Description:

Would you like to join an international company with excellent development opportunities and an open work environment where your contributions will make a difference, as you take on CMC responsibility for one of our products and a development projects?

You will be part of our Small Molecule team, which is responsible for all global regulatory CMC activities during development, registration of worldwide market expansions and CMC lifecycle activities for small molecules and peptide products.

Your day at Ferring

Collaborating with stakeholders (e.g., manufacturing sites, QA, and the supply organization), project teams, and colleagues within Regulatory Affairs, your primary focus will be lifecycle activities for a well-established product within the Small Molecules team. Depending on your experience level, you may also contribute your expertise to a product in the early phases of development.

Your main role will be to:

Take responsibility for the CMC part of regulatory submissions and approvals for worldwide market expansions;
Provide regulatory CMC strategies and expertise to cross-functional teams such as global regulatory project teams, CMC teams, product teams, and launch teams;
Perform regulatory impact assessments of CMC changes the established products/ drug substances and potentially for the development projects;
Ensure adequate documentation is generated, submitted, and approved on time worldwide;
Drive and execute scientific advice with national Competent Authorities concerning CMC activities;
Participate actively in the development and optimization of our departmental and working processes.

Behind our innovation - there’s you

We are looking for a colleague who can independently run variations and act as a representative for GRA CMC in project teams. With your understanding of the regulatory requirements, you can weigh in when determining the best strategy for any given project.

To do so, you will need:

M.Sc. in life science or pharmacy;
+3 years of experience in global regulatory affairs (preferably within regulatory CMC activities and development projects);
+7 years of experience from a similar global RA position (for Senior position);
Proactive mindset and a desire to find innovative solutions to regulatory challenges;
Great collaboration and negotiation skills – you see teamwork as the road to success.

You must have a proactive mindset and a desire to continuously develop and find innovative solutions to regulatory challenges, which you are able to communicate well verbally and in writing. In addition, you are well-organized and can plan, execute and meet deadlines. You have good negotiation skills and can deal with ambiguity. You are a true team player and are keen on working in a multicultural corporate environment.

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