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Senior Staff Regulatory Specialist, Pharmaceutical R&D - Hybrid

Cary, IL 60013

Posted: 04/04/2024 Employment Type: Direct Hire Industry: IT Project Manager Job Number: 20557 Pay Rate: $150,000 - $170,000

Job Description

Join a Fortune 500 company in medical device and pharmaceuticals! 

Hybrid - Monday, Tuesday and Wednesday will be onsite at the R&D NPD facility - R&D focused role
Focus will be on Pharmaceutical IND, and NDA - regulatory and submission work
FDA and International

MUST HAVE Pharma Regulatory submission experience!


What you will do

As a Senior Staff Regulatory Specialist, you will be exposed to a diverse product portfolio that includes pharmaceutical, cosmetic and medical device products. The ideal candidate will have strong project management skills including the ability to communicate effectively to a diverse set of stakeholders. In this role, you will:


• Prepare and author FDA INDs and NDAs, as well as annual reports.

• Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents, and in-house policies upon review of Change Control Documentation.

• Assess and author amendments and supplements to product marketing applications.

• Provide regulatory guidance to other departments for planned changes.

• Provide a critical detailed review of technical documentation prior to FDA submission.

• Compile information and data pertaining to regulatory and project requirements including assessing needs; identifying the project’s critical factors; presenting decision-makers with options; and applying strategies.

• Communicate with regulatory agencies regarding pre-submission strategies/regulatory pathway development, submissions, and follow-up on submissions in review.

• Serve as partner to marketing, engineering, clinical and quality on project and product development teams.

• Improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities.


What you need

• A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.

• A minimum of 7 years of experience in an FDA or highly regulated industry required.

• A minimum of 5 years in a Regulatory Affairs role required.

• Must have pharmaceutical experience. Experience with medical device products would be a plus.

• Experience as primary liaison to regulatory authorities as well as experience authoring, reviewing and managing components of regulatory submissions.

Our benefits:

  • 12 paid holidays annually

  • Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

  • Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Meet Your Recruiter

Sean Goulding
Vice President – Technical Recruiting, Skilled Labor, Accounting And Finance

Sean has over 8 years’ experience with Mattson Resources and over 20 years in executive search, technical recruiting, and staffing. With a Bachelor’s in Business Administration and a concentration in Human Resources as well as 16 years agency experience and 4 years corporate in staffing – Sean and his team can assist in all areas of search for your hiring needs. In agency search, Sean has led teams and recruiting services for Engineering, Sciences, IT, Skilled Labor, Operations, Supply Chain, Operational Excellence and more for Medical Device, Pharma, Aerospace, Automotive, Distribution, Transportation, IT Services, Software, Food & Beverage, Retail, and Consumer Products. In 2021 Sean oversaw Mattson Resources expansion and opening of a satellite office in Corona, CA.

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About Cary, IL

Discover your next career move in the vibrant area around Cary, Illinois! With a blend of picturesque landscapes, a thriving job market, and a tight-knit community, this region offers unparalleled opportunities for personal and professional growth. From the beautiful Moraine Hills State Park to the renowned Raue Center for the Arts, there's something here for everyone. Explore job listings in this charming locale and take the first step towards a fulfilling career in the heart of the Land of Lincoln. Join us in embracing the enchanting culture and endless possibilities that await in Cary, Illinois!