Senior Regulatory Affairs Scientist

Description SENIOR REGULATORY AFFAIRS SCIENTIST

Clinical Research Management, Inc. (CRM) is a Government Contractor specializing in infectious disease research in the U.S. and aboard. CRM provides GxP services, research personnel, and support services, contributing to the development of vaccines, drugs, and devices, to help prevent, diagnose, and treat human disease. CRM has an immediate need for a Senior Regulatory Affairs Scientist in Frederick, Maryland.

RESPONSIBILITIES

1. Serve as a core member of integrated product teams (IPTs) and team leader of internal regulatory teams, and includes: review, editing, and coordination of document submissions to the FDA; identifying regulatory issues that need input of other regulatory SMEs and obtaining that input; aiding with clinical and nonclinical protocol development and review; providing guidance and regulatory strategy; coaching IPTs in the conduct of meetings with the FDA; and serving as a point-of-contact with regulatory staff of external collaborators.
2. Identify and provide guidance to product managers on key regulatory issues and strategy.
3. Develop responses to FDA questions, review and edit regulatory documents in conjunction with product managers and regulatory team.
4. Assist in collection of documents, management and oversight to sponsor regulatory files of assigned products.
5. Prepare SOPs, work instructions, and validation plans for support activities.
6. Provide one-on-one and small training sessions for less experienced staff.
7. Complete all other functionally related assigned duties.

Requirements REQUIRED SKILLS / EXPERIENCE
 
1. Possess a minimum of a master's degree in biomedical science or equivalent experience. 2. Have 5 years experience in reviewing eSubmission ready documents for completeness.
3. Demonstrate an understanding of the FDA eCTD process.
4. Demonstrate significant experience in advising product development teams on regulatory issues.
5. Demonstrate skills in coordination of regulatory activities within internal and external teams. 6. Possess strong verbal and written communication skills.
7. Demonstrate the ability to work well with personnel of diverse backgrounds and experience; manage conflict constructively.
8. Demonstrate training and experience in GLP studies and GCP Regulations.
9. Must be a US Citizen to comply with the DoD Facility Security Requirements.

ATTRIBUTES
 
CRM currently offers the following benefits to full-time employees:
• Paid vacation, sick and holiday leave.
• Up to $3,000/year for Tuition Assistance.
• Up to $500/year for Professional Development Assistance.
• Health, Life & Disability Insurance.
• 401k Retirement Plan with Employer Match.
• Flexible Spending Accounts
• Voluntary Benefits – Dental, Short-Term Disability & Supplemental Life Insurance.
• Other Benefits.

Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under CRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.

CRM is an Affirmative Action-Equal Opportunity Employer

* Please submit only one resume per position.
** Contact will only be made if there is further interest.
*** All posted opportunities are full-time, unless otherwise stated.

**** All candidates can apply at www.clinicalrm.com under the career opportunities section by selecting the position of interest and then the “apply to this job” link at the bottom of the job posting.