Regulatory Affairs Associate II

Job Description

Job Description

Regulatory Affairs Associate II
Hybrid working once fully trained.
More on site presence whilst training.

Role Purpose:
Regulatory contractor for data management including data entry, review and labeling revisions.
Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
Ensures that labeling is in compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.
Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
May identify submission components, communicate documentation standards and coordinate assembly of labeling components for regulatory dossiers.
May review labeling, extract pertinent information, prepare information abstracts and executive summaries of material searched.

Major Accountabilities:
To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional artwork review and preparation, and to contribute to the achievement of functional objectives.
Applies company policies and procedures to resolve routine issues.
Contacts are primarily with labeling team and other personnel in department or group. Works on problems of routine scope.
Follows established policies and procedures.
Normally receives detailed instructions on all work.

Education & Qualifications:
BS in science or relevant field.
Pharmaceutical and Regulatory Experience a plus.
Experience: Pharmaceutical and Regulatory Experience a plus.
Competencies: Computer literacy required. Strong organizational skills required.
Typical activities may include work at a computer, copying, scanning, filing and, dependent on the position, considerable time may be spent sitting, standing or walking.
Light lifting (up to 10-15 lbs.) may be required from time to time, consistent with an office environment.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Skills & Knowledge:
Proficient in computer entry, Word, Excel, Powerpoint and internet use.