Due to continued success we are looking for a Regulatory Affairs Director to join a established and growing Biotechnology business.

Client Details

I have partnered with a well known and fast growing Biotechnology business who invent , develop and commercialize life changing medicines for people with serious diseases all around the world. With products spanning across multiple therapy areas and multiple phases this business has some very ambitious growth plans over the next 5 years.

Due to continued success this is a new Regulatory Affairs Director - Oncology position , this role will be based out of the Dublin head office and this person will be required to work to a Hybrid model.

Description

Regulatory Affairs Director - Oncology

• Where required, lead and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team.

• Build the representation of regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.

• Assist Development teams and Regulatory senior management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes.

• Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.

• Execute clinical trial applications for assigned programs and provide leadership for team members responsible.

• Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).

• Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as the need arises.

Profile

Regulatory Affairs Director - Oncology

• 10+ years regulatory experience with a focus on supporting products through clinical development.

• Proven track record of supporting EU Clinical Trial Applications through approval and study start up.

• Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).

• Experience of monoclonal antibodies is desirable.

• Experience of bringing a product through EU approval is a distinct advantage.

Job Offer

Above Average Basic Salary, Car Allowance, 25% Bonus , Stock Options, Pension , 33 Days Annual Leave