Regulatory Consultant - Pharmaceutical

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Updated: December 17, 2019
Location: Morrisville, NC, United States
Job ID: 5807

Overview

You’re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

 

Responsibilities

You’ll join The Scientific and Medical Affairs Advisory Group within the Syneos Health Global Regulatory Consulting team, where you will help make medical organizations more effective, particularly in complex specialty markets, while giving products the strategic support they require. You will provide regulatory and technical support for assigned product development projects including product development documents and regulatory agency submissions.

Essential Functions:

  • Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses or product development plans.
  • Contribute to or prepare administrative and technical components of regulatory agency submissions for the conduct of clinical trials, for product registration, and for post-approval maintenance, in electronic common technical document (eCTD) format.
  • Prepare briefing packages for regulatory agency meetings or advice and contribute to or support to these agency interactions.
  • Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, budgets, and strategies.
  • Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
  • Provide administrative support for project management including (invoices, time and budget management, application maintenance activities  and other operational activities).
  • Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
  • Prepare training materials and share best practices in the regulatory area, both internally and externally.
  • Participate as regulatory support in internal or external project audits.
  • Participate as regulatory support on internal cross-functional initiatives.
  • Travel may be required (up to 10%). 

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has: 

  • BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. 
  • Moderate pharmaceutical/medical device related experience.  One to three years’ experience in regulatory affairs. 
  • Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, NDA, CTD (including electronic submissions), PMA, CTA, and MAA. 
  • Experience working in an independent office environment. 
  • Excellent customer service and interpersonal skills, with the ability to work both as a team member and independently. 
  • Excellent written and verbal communication skills. 
  • Good quality management skills. 
  • Computer literacy in MS Word, Excel, and PowerPoint. 
  • Ability to interact with staff from multiple departments and offices to establish project standards. 
  • Good initiative, adaptability, and pro-activity. 
  • Good attention to detail.

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality of life balance.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, you’re a part of the big picture. We work hand in hand to guide pre-market development through post-market commercial strategy. Knowledge sharing across advisory groups unlocks the innovation and unique strategies our end-to-end commercialization projects require. Our collaborative mindset means every project is a chance to solve a new challenge, learn from your teammates, become better-rounded, and evolve your career.


WORK HERE MATTERS EVERYWHERE | How will you accelerate biopharmaceutical commercialization?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

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