Chipton-Ross - Regulatory Affairs Associate

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: 214014 - Regulatory Affairs Associate
Industry: PRO
Region: NY-New York
City: Remote
State: NY
Rate: Up to $66.82 DOE
Duration: 12 months
Description: Chipton-Ross is seeking a Regulatory Affairs Associate for a remote contract opportunity.

JOB SUMMARY:
Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of company's products.

BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):
- Scientific knowledge
- Written and verbal communication skills
- Knowledge of regulations
- Technical systems skills (e.g. word processing, spreadsheets, databases, online research)
- Proofreading and editing skills
- Ability to contribute to multiple projects from a regulatory affairs perspective
- Ability to multitask and prioritize Include the education and experience that is necessary to perform the job satisfactorily.
- Bachelor's degree or country equivalent in pharmacy or related scientific discipline with 0-2 years regulatory experience, preferably within a healthcare environment.

POSITION RESPONSIBILITIES:
- Track of status and progress of regulatory documentation
- Review, edit and proofread regulatory documentation
- Assist in preparation and review of labeling, SOP's, and other departmental documents
- Compile under supervision regulatory documents for submission
- Participate as an active team member of project teams as required,
- Compile and prepare responses to regulatory authorities questions
- Maintain regulatory files in a format consistent with requirements
- Maintain awareness of regulatory requirements
- May be responsible for a specific product portfolio in the region

REQUIRED EDUCATION:
Bachelor's degree or country equivalent in related scientific discipline

WORK HOURS:
First Shift, Full Time
Position can be fully remote or hybrid if local to Skaneateles, NY area
RMT
: Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
Contact: Tyler Harrell
tharrell@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x307 or (800) 927-9318 x307

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.