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Miles
Km80.5

Director, Regulatory Affairs

Therapeutic Proteins International, LLC

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Location: Chicago, IL Posted Date: 4/25/2013 Position Type: Full time Job Code: DRA001 Required Education: Bachelors Degree Areas of Expertise Desired: Regulatory Affairs

Description

Therapeutic Proteins International, LLC (TPI) is a world-class developer and commercial manufacturer of finished biosimilar recombinant therapeutic protein products. TPI's products are manufactured in cGMP/BLA compliant facilities using proprietary
and patented technologies for both mammalian and bacterial expression systems at globally competitive cost. Located in the heart of Chicago, TPI is supplying the US FDA approved biosimilar cytokines and monoclonal antibodies globally to help reduce
the cost of treatment to patients worldwide.

We are seeking a Director of Regulatory Affairs that will:

1. Lead innovative regulatory strategy development for all phases of drug development for biological investigational products.
2. Implement and deliver the global regulatory strategy for assigned products and programs.
3. Monitor changes in the global regulatory environment, both general and specific to the therapeutic area and support and advise project teams accordingly.
4. Develop global regulatory strategy reflective of applicable domestic and international requirements.
5. Conduct regulatory risk planning and mitigation for programs assigned.
6. Develop and implement innovative strategies to maximize the likelihood of regulatory success. Effectively communicate objective assessments of the likelihood of success for regulatory strategies.
7. Strategically plan, lead, coordinate, prepare and execute meetings and teleconferences with regulatory agencies.
8. Effectively collaborate with other functions and influence product development decisions.
9. Monitor product related corporate activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices.
10. Represent Regulatory Affairs and provide guidance to Research, Development, Clinical and Manufacturing at all Team meetings.
11. Interact with responsible departments and oversee the review, and assembly of the scientific (preclinical, clinical, and manufacturing) and administrative sections of submissions to regulatory agencies.
12. Submit regulatory information to FDA and world-wide regulatory agencies including, BLAs, and manufacturing, preclinical and clinical protocols and amendments, and adverse experience reports.

Requirements

Position:
A minimum of 5-7 years of experience in Regulatory Affairs. Knowledge of FDA regulations required. Strategic regulatory experience in biological products required. Direct liaison experience with FDA required.

Regulatory experience in biosimilar products is highly desired.

Knowledge of international regulatory guidelines, GCP and cGMP requirements are desirable.

Education:
Advanced Degree in science or equivalent combination of relevant educational and professional experience is required.

TPI, LLC does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on TPI’s approved agency list. Unsolicited resumes or candidate information submitted to TPI by search/recruiting agencies not already on TPI’s approved agency list shall become the property of TPI, LLC and if the candidate is subsequently hired by TPI, TPI shall not owe any fee to the submitting agency.

TPI, LLC is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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