Senior Technical Writer – Regulatory (CMC)

Fuldtid

Permanent

København, Tårnby

SE PÅ KORT

ID: 2564783

Indrykket for 37 dage siden

Job Description:

Do you have deep insight into regulatory documentation on CMC development and manufacturing of pharmaceutical products? Are you looking to join an international environment with excellent development possibilities and opportunities to work with complex biological pharmaceuticals?

We are expanding our Technical Writing team and looking for an experienced colleague who wants to help set the company quality standard for our CMC documentation and contribute to the continuous development of our ways of working across development and technical operations.

Ferring + you
You will join the Technical Writing team within Global Regulatory Affairs. We are responsible for global regulatory CMC writing of regulatory documents in applications for new approvals, worldwide market expansions, and product lifecycle activities. We work with a variety of pharmaceutical products, including small molecules, peptides, biologicals, recombinant products, and gene therapy.

Stepping into an informal and collaborative environment, you will have close interfaces with many different disciplines, including Global Pharmaceutical R&D, manufacturing sites, Product Supply, Quality Assurance, Ferring affiliates, and development sites around the world.

Your day at Ferring
As a senior technical writer, you will work closely with colleagues in the Global Regulatory function and manufacturing sites to drive and ensure CMC documentation readiness for regulatory applications.

You will be responsible for authoring CMC documentation to be submitted in applications to authorities for our global products, and you will ensure high quality and the appropriate level of detail in documents included in the CMC dossiers.

Your work includes new drug applications (NDAs), variations, renewal applications, and documentation supporting responses to authority inquiries. Moreover, you will provide input to regulatory impact assessments of change for approved products and drug substances, ensuring that change applications are submitted and approved on time.

You will also:

Provide regulatory CMC advice to other functions in the company

Provide guidance, as needed, to manufacturing sites regarding specifications, process validation, and stability protocols

Write briefing documents and material for scientific advice meetings with authorities

Your workplace will be our spectacular and state-of-the-art office building, Soundport, near Copenhagen Airport.

Behind our innovation – there’s you
You are comfortable independently driving your projects while also being open to sharing your know-how and experience to help your colleagues drive theirs. As you strive for high-quality work, you enjoy finding innovative solutions in a dynamic regulatory environment and can deal with ambiguity.

In addition:

You have a master’s degree in life science (pharmacy or chemistry)

You bring deep insight into product CMC development and manufacturing

You have global experience working with pharmaceutical products – i.e. positions where you have worked with regulatory submission documentation, such as global regulatory functions or a manufacturing site QA entity

You have experience writing and reviewing CMC submission documentation and responding to questions from health authorities

You have excellent English communication skills, both verbally and in writing

You are keen on working in a multicultural corporate environment

People come first at Ferring
Our philosophy of ‘people come first’ flows through every part of the business. Our future is shaped by a science-driven approach, a passion to lead, and a need to collaborate and develop long-lasting relationships to ensure our focus remains on innovation.

We succeed in making a difference in the lives of millions of people by working together. Our diverse backgrounds, experiences, expertise and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions.

Behind our purpose – there’s you

If our mission and your vision are aligned, please apply. Kindly include a few lines regarding your motivation for applying in the CV or a cover letter. Please note that we review applications continuously and close the process when we find the right match.

If you have questions about the role, please reach out to Jens Ekelund, Director, Global Regulatory Affairs Compliance Excellence, at +45 2878 7641.

We are unable to offer relocation assistance for this position. Candidates must be located in the Oresund region or willing to relocate at their own expense.

Location:

Ferring Denmark

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