Senior Staff Regulatory Specialist, Pharmaceutical R&D - Cary, United States - Mattson Resources

Mattson Resources Cary, United States

3 weeks ago

Description

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:

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.

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