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Regulatory Affairs Manager

Chicago, IL 60611

Posted: 05/24/2023 Category: Pharmaceutical Job Number: 283090-0_1 Salary: $130,000

Job Description

Smith Hanley Associates
Regulatory Affairs Manager
Remote/Permanent
Nihar Parikh- [email protected]

Responsibilities:
Support or manage interactions with FDA and other health authorities on CMC issues.
Formulate, lead and drive CMC regulatory strategy for development projects or marketed products.
Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to project teams in a timely manner.
Lead and drive all CMC submission activities as well as make quality regulatory decisions.
Provide regulatory support to other company functions during inspections.
Serve as Regulatory Affairs representative and participate in assigned due diligent business activities.

Requirements:
Advanced degree in Pharmacy, Science, Engineering, or Health related field.
5+ years of pharmaceutical experience as well as regulatory CMC experience required.
Ability to take innovative ideas from proof of concept to promote a successful product regulatory CMC submission and increase probability of regulatory approval.
Knowledge of pharmaceutical industry regulatory affairs CMC discipline throughout the product lifecycle, with awareness of preclinical, clinical, commercialization, and operations.
Knowledge of current and emerging issues and trends of the pharmaceutical regulatory environment.
Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
Ability to interpret Regulatory Authority policies and CMC guidance and apply them as appropriate in product development and post-approval activities.
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by the data.

www.smithhanley.com

Meet Your Recruiter

Nihar Parikh
Executive Recruiter

Nihar specializes in the clinical domain and works across biostatistics, clinical trials/research, data management, health economics/RWE, medical affairs, statistical programming, and other R&D areas within pharma and biotech. He has more than ten years of recruiting experience and attributes his success to the ability to build good relationships, listen attentively, be proactive, continuously self-improve, and show empathy. Nihar plans to carry Smith Hanley’s stellar reputation in the pharma business for many years to come. Outside of work, Nihar likes to spend his time following Chicago sports, travel, podcasts, yoga, golf, and investing. 

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