About Us

PATRIN PHARMA, Inc., headquartered near Northside of Chicago in Niles, is a diversified pharma company serving patients in need by developing, and marketing high quality branded and generic prescription, Devices and Nutraceutical and OTC pharmaceutical products.

About the Role

The Regulatory/Compliance Scientist position has a two-fold responsibility. (S)He is responsible for independently monitoring, conducting active vigilance for FDA compliance to current ANDA applications, aware to new guidance and reporting appropriately to the senior management and preparing supporting documentation. A second aspect of the role is to be performing CMO audits on raw material, in-process and finished product processes and compliance to FDA regulations. All work will be conducted in accordance with standard regulatory framework including supplier audits and compliance. This is an ideal position for an independent & passionate for FDA regulatory compliance individual. This is a in-person position. Please do not apply, if you do not meet all of the requirements for the position. Principals ONLY.

Position Responsibilities

Responsibilities include but are not limited to:

Perform review of current FDA applications (approved, under review and post-approval) for current regulations and draft guidance.
Provide accurate assessment of all products and compliance status, develop an effective program to monitor and execute future submissions.
Conduct supplier/CMO audits and provide an assessment for the compliance of GMP and the FDA regulations pertaining to our products.
Develop a program to monitor and perform routine audits.
Provide regular monitoring reports to the senior management.
Perform other duties as assigned or requested.

About You

Bachelor’s degree in chemistry, pharmacy, biochemistry or closely related field/major.
Pharma Regulatory Expertise – 3-5 years' experience, with 2+ years' experience with ANDA/510K and other regulatory role preferred.
Compliance – 1-3 years' experience preferred, in a pharma/nutraceutical/OTC field with QA role. Hands-on supplier qualification/audit experience is highly preferred.
Ability to read, interpret and develop plans for the regulatory compliance and written procedures.
Attention to detail.
Ability to work with minimal supervision - a self-starter
Problem solving skills
Organization, communication and interpersonal skills.
Understanding of good laboratory practices, GMP/GLP/cGMP and analytical techniques.

APPLY WITH A RESUME AND SALARY REQUIREMENTS TO: HR(at)Patrinpharma.com and not via LinkedIn.

Benefits & Perks

Medical
Education Assistance Program
Retirement Savings Plan
Company Paid Holidays
Generous vacation policy
Other Paid Leave
Opportunity to advance with responsibilities within a growing company

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