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Rockbridge Search & Recruitment 08/03/2021

Senior Regulatory Officer

Ref #: 401
Location: Washington Washington 98226
2021-06-08
Salary: $125k-$145k
Sector: Life Sciences
Type: Permanent

The Senior Regulatory Officer (RO) is a member of the Regulatory Team. The RO assists with and/or is responsible for writing regulatory submissions and routine regulatory reports for all registered products. The position involves managing regulatory files and verbal and written communications with numerous regulatory agencies.

Key Performance Indicators
  • Successful completion of regulatory submission documents within the project timelines.
  • Successful completion and on-time submission of regulatory reports.
  • Effective document tracking for all regulatory documents.
  • Approval of new submissions by regulators.
  • Acceptance of regulatory reports by regulators.
Core Functions
  • Translates science-based information into regulatory reports and documents.
  • Completes quality documents for regulatory reports and submissions in a timely manner.
  • Communicates within and between the company’s departments on regulatory matters, most often but not limited to Quality Assurance/Quality Control (QA/QC).
  • Communicates with regulators as appropriate.
Winning Behaviors, Competencies, and Skills
  • Meticulous attention to detail
  • Good organizational skills
  • Good time management skills
  • Takes pride in quality of work
  • Takes initiative
  • Good problem-solving skills
  • Good team player

Personality and communication (soft skills):

  • Positive attitude
  • Engages well with co-workers and external contacts for the company
  • Efficient, expedient, and innovative
  • Strong communication skills – good listener and communicator
  • Keen learner, who continually strives to improve skills and knowledge

Hard skills:

  • Strong scientific/regulatory process and submission skills
  • Experienced project planning
  • Familiarity with aquatic animal health
  • Familiarity with basic pharmacology
Experience

Education:

  • Bachelor’s or more advanced degree in regulatory sciences or other associated discipline.

Work Experience:

  • Practical experience in preparing, submitting, and attaining drug approvals.
  • Experience with regulatory programs and third-party certification programs.
  • Experience with regulatory programs in pharmaceutical, food safety or aquatic animal health.
  • Experience in pharmaceutical industry, pharmacy, and/or chemical or pharmaceutical manufacturing.

Industry Knowledge:

  • Working knowledge of the US and Canadian regulatory process and requirements for drug submissions and approvals.
  • Familiarity with aquatic animal health aspects of aquaculture and aquatic ecosystems/conservation.
  • Familiarity with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and/or Good Laboratory Practices (GLP).
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