Clinical RA Director -Hibrid position

Primary purpose and function of this position:

Provide clinical regulatory perspective for development and registration of the company's products, including evaluation of alternative regulatory strategies for clinical development and submission to EU/US and other territories as defined by the company.

Major duties and responsibilities:

· Regulatory support for the clinical function

· Review strategic documents pivotal for NDA/MAA submission (protocols, reports, etc.)

· author and maintain clinical aspects of regulatory documentation (such as IMPD, IB, IND).

· Prepare and attend consultation meetings with regulatory agencies as needed.

· Top responsibility for clinical parts in regulatory submissions to FDA, EU and other territories regulatory entities.

· Supervise clinical Regulatory Affairs consultants as required.

· Track, interpret, and advise on US and European regulations, guidelines, procedures and policies within the company's scope.

· Regulatory intelligence

Competencies:

· Leadership without authority

· Excellent interpersonal relations

· Proven Project management capabilities

· Global regulatory experience preferred in NDA/MAA submission

· Experience with drug-device combination product/s

· Perfect English

· Self motivated and proactive

· Experience in global pharma

· Flexible thinking/ creativity

· Life science background

Education and knowledge requirements:

10 years clinical regulatory experience in pharmaceutical industry (preferably in CNS).