Executive Director, Clinical Regulatory Affairs

Job ID: | Position Type: Full time-Exempt

location

Remote

Pharmatech Associates is a well-established, global consulting firm known for deploying technically superior, highly dedicated, professional project teams.  Our Pharmaceutical, Biotech and Medical Device clients are located throughout the USA and Internationally.

 

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.
  • Maintain an awareness and understanding of changes to Global International regulatory requirements as it relates to current drug therapy categories with the goal of assessing potential impact on current client operations.

 

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

What you’ll like most about working with our team at Pharmatech Associates:

  • Everyone at Pharmatech Associates contributes to the success of our projects, departments and company.  Your input will not only be heard; it will be encouraged and valued.
  • We are consultants, and you will move from project to project.  You will have endless opportunities to learn and grow your career.
  • Your coworkers are a group of highly intelligent and motivated employees.  There will always be someone in-house that has done the job you were hired to do, and you will be able to learn from them.
  • We take great pride in offering our employees the best benefits and competitive compensation packages in our industry, plus performance-based bonus incentives.
  • Fantastic co-workers and no internal politics!  A culture that thrives on true collaboration.

 

About Pharmatech Associates

 

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

 

 

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.

Apply:  Please send your resume to careers@pai-qbd.com