Home >> About Us >> Careers

Senior Consultant – Regulatory Affairs

This individual will provide scientific and regulatory expertise regarding preclinical and clinical aspects of drug development for our clients; prepare and/or review regulatory submissions to support clinical trial and marketing authorization activities; and provide regulatory support for assigned projects.

Responsibilities

• Acts as a Regulatory Team Leader on complex projects, which may include technical writing.
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
• Keeps up with current regulatory knowledge, trends, and developments in Europe and the US.
• Identifies project needs, tracks timelines, implements client requests and manages day-to-day workload in collaboration with senior staff.
• Understands the Scope of Work, deliverables and management of budget for any given project.
• Actively manages projects and employees by providing coordination and thought leadership; prepares project plans, defines and assigns tasks, assures resource availability.
• Proactively seeks opportunities to promote our firm, directly or collaboratively, by regularly publishing articles and securing outside speaking engagements.
• Consistently increases the value of the client's business through the successful completion of tasks - on time and within budget.

Qualifications

• Masters or Doctoral Degree in a scientific discipline, with at least twelve years of regulatory experience in a pharmaceutical company or in a regulatory agency.
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines.
• Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results in a regulatory environment.
• Extensive knowledge of regulations relevant to drugs and biologicals in Europe and the US.
• Comprehensive understanding of clinical drug development process.
• Good, solid interpersonal communication (oral and written) and organization skills.
• Strong software and computer skills, including Microsoft Office.
• Demonstrates self-motivation and enthusiasm.
• Demonstrates negotiation skills and is confident in making decisions with minimal supervision.
• Ability to work on several projects simultaneously, retaining quality and timelines.

The Weinberg Group offers a very competitive salary and benefits package that includes medical, dental, short- and long-term disability insurance, life insurance, group long-term care insurance, a selection of voluntary benefits, 401(k) plan with generous matching contribution, and tuition reimbursement.

To apply, please send your cover letter and resume to careers@weinberggroup.com and reference position code RA-09.

The Weinberg Group
1220 Nineteenth St, NW
Suite 300
Washington, DC 20036

Selected a "Great Place to Work" by Washingtonian magazine


EOE