Regulatory Affairs Associate Director

Job Title: Regulatory Affairs Associate Director
Contract Type: Permanent
Start Date: April 2016
Contact Name: Gerry Kennedy
Contact Email:
Job Published: over 6 years ago

Job Description

Regulatory Affairs, Associate Director          Dublin

Our client is a young exciting multinational biopharmaceutical company enjoying exceptional growth combined with a strong high potential pipeline. Rapid expansion has led to the need to create a  management position in Regulatory Affairs to be based in their Dublin office

This is an exciting opportunity to join our growing Regulatory Affairs team based in Dublin and contribute to shaping clinical development programs to meet the needs of EU and other ex-US regulatory stakeholders.  The right candidate for this role will be a self-starter with strong experience of clinical development and regulatory filings for biologics. The ability to work both independently as well as part of a cross-functional team, and lead direct interactions with EU regulatory agencies will be required. Experience in the neurology or oncology therapeutic areas would be an advantage.

The Job Spec 

- Assist Development teams and Regulatory Senior Management in developing Regulatory strategies that are EU appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways, to expedite development.

- Lead interactions with EU regulatory agencies at both national and central level, and assist internal teams in navigating such interactions.

- Build the company's regulatory profile in the EU, and serve as a resource for EU knowledge for the global clinical development organisation.

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

- Provide support to specific program teams to address a range of issue including submission of clinical trial applications, developing responses to CTA challenges and provision of CRO oversight as required.

The Person Spec

- Advanced degree in a scientific discipline.

- 8-10 year’s regulatory experience with a focus on supporting products through clinical development.

- Proven track record of supporting EU regulatory applications (e.g. Clinical Trial Applications, Marketing Authorisation Applications, Paediatric Investigational Plans, and Scientific Advice).

- Experience of directly working with national regulatory agencies and leading agency meetings face to face.

- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) is an advantage.

- Ability to negotiate and concisely express clear positions to stakeholders at all levels.

- Excellent written and verbal communication skills.

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

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about our clients unwavering commitment to combining good science & good business.

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