Executive Director - Clinical & Regulatory Affairs

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Published date: October 17, 2020 10:59 am

Modified date: October 17, 2020 11:07 am

Location: Hayward, California, United States

About the Job

We are looking for an Executive Director, Clinical and Regulatory Affairs to join our consulting team and provide market leadership, develop and execute science based clinical and regulatory solutions for the Life Science industry.

This is a salaried position with bonus and benefits, full-time staff position.

We’re looking for thought leaders who:

Provide market segment leadership and subject matter expertise for the Clinical and Regulatory Affairs sphere.
Develop and execute science-based clinical and regulatory affairs solutions for the regulated life sciences industry.

Must be able to speak to and demonstrate knowledge in the following areas: drugs, biologics, nutraceuticals, homeopathic drugs, IVD, medical devices and combination products as it relates to clinical and regulatory affairs primarily in the US, EU and other international markets

Accountable for growing Pharmatech’s Clinical and Regulatory Affairs sphere through sales development, outstanding project management and exceptional client relationship management.

As a member of the senior leadership team, participate in strategic and operational decision-making processes necessary for the successful attainment of the organization's initiatives.

Primary responsibility for managing all aspects of Profit & Loss performance including resource allocation, project proposal development, expense control and the development of annual budgets and monthly forecasts.

Assemble world-class consulting teams by actively supporting recruitment efforts, including negotiating compensation, and providing growth and mentorship opportunities.

Champion and execute Pharmatech’s culture to heighten employee engagement and maximize retention of top talent. Prepare and communicate annual performance reviews.

Qualifications:

Bachelor or Master’s Degree with a scientific or engineering related major is required, PhD is a nice to have

Strong leadership skills with at least 10 years of demonstrated leadership and experience in the regulatory affairs area within the regulated life sciences industry
Strong background in non-clinical and clinical studies is needed

Must have experience with eCTD Modules 4 and 5
Must be able to understand ICH Guidelines, Quality, Safety, Efficacy and Multidisciplinary guidelines

Experience with Monoclonal Antibody, CAR-T and cell/gene therapy
Experience running a successful and profitable clinical and regulatory affairs consulting practice is a plus

Expertise in following registrations: BLA, IND, NDA, 510K (including De Novo) devices, Pre-Market Approval (PMA) devices, MAF’s, IVD, NDA, ANDA, IND and BLA for pharmaceutical and biotech products

Strong technical writing capabilities specific to regulatory activities

Outstanding personnel management skills and demonstrated leadership capabilities with a proven ability to work cross-functionally within client organizations

Able to effectively communicate to various audiences, including C-level and BOD level client personnel. Exceptionally strong written and oral communications is a must

Capable to travel and work remotely at client sites throughout the United States and internationally

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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