Senior Staff Regulatory Specialist, Pharmaceutical R&D - Hybrid Jobs in Cary IL \ IT Project Manager Job Recruiters - Mattson Resources

Hybrid - Monday, Tuesday and Wednesday will be onsite at the R&D NPD facility
Focus will be on Pharmaceutical IND, NDA and CMC Module 3 - regulatory and submission work
FDA and International


MUST HAVE Pharma R&D 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:

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  12 paid holidays annually
  
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  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.
  
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  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.