Regulatory Consultant

Updated: July 2, 2019
Location: Morrisville, NC, United States
Job ID: 3857

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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.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developedand commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 23,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

Responsibilities

This opportunity is with Syneos Health Consulting, an industry-leading consulting firm specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You’ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop achievable strategies for our clients. High-level details in one sentence about the role. More specifically:

Summary:

Provide regulatory and technical support for assigned product development projects, including product development documents and regulatory agency submissions, implementing/managing project regulatory activities, and supporting clients and project teams.

  

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.

 

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, flexibility, and open to suggestions. 
  • The drive for self-development, the ability to collaborate, and an action-oriented work ethic

Full Syneos Health Consulting benefits which include:

  • Generous paid time off and company paid holidays
  • Domestic Partner Coverage for: medical, dental, vision, and voluntary life insurance
  • Medical – Cigna; Dental – Delta Dental; Vision - EyeMed
  • Company Match 401K - $0.50 per dollar up to 9% of salary
  • Eligible to participate in Employee Stock Purchase Plan
  • Flexible Spending Accounts: Health Care and Dependent Care
  • Company-paid Basic Term Life Insurance at 2x base salary
  • Optional Supplemental Term Life Insurance (100% employee paid): for employee, spouse/domestic partner, and children.
  • Company-paid Short and Long Term Disability
  • Optional Supplemental Short and Long Term Disability (100% employee paid): employee only
  • Employee Assistance Program
  • Referral bonuses
  • Dedicated training and support

Make your work matter everywhere. Be a driving force in a rapidly evolving healthcare industry.

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

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