Employment Opportunities at Epic

Epic is an Equal opportunity employer

Non-discriminatory and anti-harassment policies in place

Americans with disabilities act policy

EPIC BENEFITS

Retirement benefits- 401 K

Capped tuition

   reimbursement

PTO

FMLA, NYSSP

Paid company holidays

Bereavement

Jury duty

Medical insurance

Disability Insurance

   (short and long term)

Vision Insurance

Workers comp

Paid company holidays

Unemployment

Lockers (if applicable)

Free parking

 

August 17, 2018

SENIOR REGULATORY AFFAIRS ASSOCIATE

Position Summary:

The Senior Regulatory Affairs Associate will review and prepare regulatory documents related to ANDA submissions.  Prepare submissions for projects/products covering product development, registration, approval and post approval activities for ANDAs/NDAs.  This individual will be part of project teams, and provide Regulatory insight and direction.  Review and compile Regulatory submissions.  Must have excellent written and effective verbal communication skills, be proficient in project management, and be a flexible individual able to work in a fast paced environment.

 

This is an Exempt, Salaried position.

 

Minimum Requirements:

BS in Pharmacy, Chemistry or related discipline

2 – 3 years experience in pharmaceutical regulatory affairs.

Experience in Generic Regulatory filings preferred.

 

MAJOR DUTIES/RESPONSIBILITES

 

Author and compile Regulatory filings including new ANDA/NDA submissions, amendments, supplements, annual reports, safety reports.

 

Review all source documentation for scientific and regulatory requirements.

 

Review and communicate emerging regulatory requirements to ensure compliance.

 

Act as liaison between Regulatory Affairs and other functional areas

 

Represent Regulatory Affairs in cross functional meetings.

 

Interface with external regulatory groups and regulatory agencies.

 

Other daily, weekly, monthly etc., reports, tasks, projects as required in the Regulatory Affairs Department.

 

Send resumes to:

                       Epic Pharma, 227-15 N. Conduit Avenue, Laurelton, NY 11413

                       Email: hr@epic-pharma.com

 

 

Epic Pharma is an equal opportunity employer and offers a competitive starting salary and benefits package including medical/dental/vision/401k.

 

Contact Us: Phone:718.276.8600 Fax: 718.949.3120   Customer Service: 1.888.EPIC.RX1