Do you have experience with submission of Biologics License Application?

Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd^® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes.

A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd^®. Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B.

As Director Regulatory Affairs you will be responsible for developing and executing global regulatory strategies to support the submission, approval and market launch of the company´s biologics. Since the organization is in a development phase, there are great opportunities to contribute during a very exciting and expansive period. The office is based in Stockholm City and you will report to the Chief Operating Officer at Diamyd Medical. Hybrid working solution is possible.

Key Responsibilities:

• Lead the strategic work for regulatory activities and ensure alignment with business goals by identifying the regulatory requirements for U.S. as well as EU and other key markets

• Provide strategic guidance on regulatory pathways for marketing authorization, applications such as Biologics License Application (BLA), clinical trials and lifecycle management

• Lead the preparation, submission, and negotiation with agencies incl FDA and EMA

• Lead and support submission activities such as BLA filing and briefing documentation for meetings

• Lead a small team of in-house regulatory professionals including contractors as necessary

Qualifications:

• Life Sciences Degree, MBA or equivalent

• Minimum of 10+ years of Regulatory Affairs experience in the biotech or pharmaceutical industry

• Proven experience in leading regulatory submissions, including Biologics License Applications to the FDA

• Extensive knowledge of global regulatory requirements, including FDA, EMA and ICH guidelines

• Demonstrated experience in global product launch preparation and post-approval regulatory management

• Highly proficient in spoken and written English

Welcome to apply via haegercarlsson.com
Questions are answered by:

Lena Sörskog +46 (0)70-692 45 70, lena@haegercarlsson.com

Anna Freese +46 (0)76-174 75 81, anna.f@haegercarlsson.com