Director of Regulatory Affairs

We are now looking for an experienced and motivated Regulatory Affairs Director to direct and develop our Regulatory Affairs function. As our Director of Regulatory Affairs you will have a central role in our growing organization.

Responsibilities

You will be providing strategic leadership and manage all aspects of Global Regulatory Affairs activities. Depending on you and your qualifications your responsibilities will include the following:

• Lead, manage and optimize the use of internal and external (CRO's, consultants and co-development partners) regulatory resources
• Develop regulatory strategies (CMC, pre-clinical and clinical) to optimize efficient international development of assigned projects
• Ensure regulatory input to any protocol, plan or report and other documents used to support product development and registration
• Ensure timely review and approval of all required documents for filing of required information to any regulatory agency
• Provide leadership for timely planning, implementation and conduct of relevant interactions with global regulatory agencies
• Ensure effective and high quality communications with regulatory agencies
• Monitor and assess impact of relevant global regulations, guidance's, current regulatory environment and competitor labeling

Qualifications

To be able to fulfill the roles successfully we believe you have most of the following qualifications:

• B.S./B.A. degree with 10 years related pharmaceutical industry experience with at least 5 years experience in development/product Regulatory Affairs, including hands on experience with FDA and EMEA interactions
• The ability to independently evaluate the regulatory implications of CMC, non-clinical and clinical data from biologics at all stages of development
• Excellent knowledge of regulatory requirement guidelines and the ability to interpret relevance for specific developmental product activities
• Good planning, organizing and decision-making capabilities; must be able to handle multiple priorities, resolve conflicts and solve problems independently

Working in Symphogen

When being a part of Symphogen you will always have a challenging job in a creative, goal-oriented, value-based biotech environment with a meaningful mission. You will be a part of a highly engaged organization with a passion of being the worldwide leading recombinant polyclonal antibody company. You will have good development opportunities, in an organization that is inspiring and growing, with focus on diversity, teamwork, commitment and you as a person. Our employment package includes warrants for all employees, bonus system, 6 week's holiday and focus on health and well-being.

Need more information?

As our Director of Regulatory Affairs, you will be reporting directly to Christian Meyer, VP of Clinical Research, Medical and Regulatory Affairs, who you are welcome to contact at +45 45265050. If you are interested in the position, please mark your application and CV "Director of Regulatory Affairs" and mail it to: job@symphogen.com no later than the 21st of April 2008. We are looking forward to hear from you!

Symphogen's proprietary technology offers a method for the production of unlimited amounts of highly purified, antigen-specific, recombinant polyclonal antibody preparations, designated symphobodies - a totally new class of therapeutic antibodies with a number of prominent advantages compared to existing antibody therapies.

Symphogen is located in 2000 m2 fully renovated and classified laboratory- and office facilities at the Danish Technical University, Lyngby, just outside the center of Copenhagen, Denmark. The Company currently employs 85 people.

Visit www.symphogen.com for more information