PuraCapRegulatory Affairs Labeling Manager

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POSITION DESCRIPTION

Title:	Regulatory Affairs Labeling Manager
Position Type:	Full-time
FLSA Status:	Exempt
Location:	Piscataway, NJ
Department:	Regulatory Department
Effective Date:	Immediately

A. POSITION SUMMARY:

PuraCap Pharmaceutical LLC. is a fast growing New Jersey based private-hold pharmaceutical company, who has operations globally. PuraCap Pharmaceutical LLC develops, manufactures and supplies pharmaceutical products to the healthcare industry in US and worldwide market, including but not limited to prescription drugs, OTC drugs, and personal care products.

Regulatory Affairs Labeling Manager will be responsible for all labeling activities within Puracap and its affiliates for Generic Prescription drug products and OTC labeling. Track, coordinate the creation, review and implementation of all Labeling activities. This candidate must have excellent written and effective verbal communication skills, proficient in project management, is a flexible individual and able to work in a fast paced environment. This role is Exempt and is not eligible for overtime.

B. MAJOR DUTIES/RESPONSIBILITIES:

Manage Labeling team across multiple sites within Puracap
Track all labeling activities to ensure customer requirements and timelines are met
Responsible for the creation, review and implementation of all labeling OTC and ANDA/NDA
Put processes and procedure in place for Labeling creation and control
Ensure compliance with all Regulatory guidelines pertaining to Labeling
Review and communicate emerging regulatory requirements pertaining to labeling to ensure compliance
Interface with external vendors as required

Additional Skills/Knowledge:

Knowledge of US OTC and prescription labeling
Detail oriented
Knowledge of labeling software
Able to handle multiple projects with good prioritization skills
Strong written and verbal communication skills.

C. ORGANIZATIONAL RELATIONSHIPS:

Report To: Sr Director Regulatory Affairs

D. MINIMUM/PREFERRED REQUIREMENTS:

Education:	BS degree
Experience:	2-3 years experience in pharmaceutical labeling required Experience with OTC and prescription drug labeling regulations

E. PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS:

Laboratory and office environment
Ability to sit for long periods of time as required
Travel 10-15%

TO APPLY:

Email cover letter with resume humanresources@puracap.com and in email subject include: “Regulatory Affairs Labeling Manager”

PuraCap Pharmaceutical LLC is an equal opportunity employer and affords equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.

If interested in applying for any of the above positions at PuraCap, please send your Resume / CV to humanresources@puracap.com