Director Regulatory Consulting - Chemistry Manufacturing and Controls

Updated: March 2, 2019
Location: Morrisville, NC, United States
Job ID: 2767

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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 the Global Regulatory Consulting group within Syneos Health Consulting, an industry-leading consulting firm specializing in the biopharmaceutical industry. We provide lab to life services guiding pre-market biopharmaceutical development through post-market commercial strategy. Our practice areas comprise: Global Regulatory Consulting, 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 the highly complex developmental, regulatory, business and market challenges to deliver successful and achievable strategies for our clients.

As a proven expert in Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development and regulatory submissions, you will be responsible for working within inter-disciplinary project teams while independently managing and authoring Chemistry, Manufacturing and Controls deliverables to clients. You will interact and collaborate with senior management and staff on client projects, operational procedures and processes within the Global Regulatory Consulting group, across groups within Syneos Health Consulting, and across Syneos Health Clinical business units, as needed.

Your major responsibilities will include:

  • Providing strategic regulatory and tactical guidance on CMC aspects of global drug and biologics development, market clearance, and life-cycle management, to client satisfaction

  • Review, revision and authoring from source documents provided by the client, of CMC sections of regulatory documents, including regulatory meeting briefing documents and module 3 sections of regulatory applications (e.g., IND, IMPD, BLA, NDA, MAA, supplements, variations) that are acceptable to regulatory authorities

  • Interacting professionally, at multiple levels within a client organization to communicate recommendations, obtain necessary information, provide status or updates to project deliverables, communicate relevant advances in the scientific or regulatory landscape, develop project plans and timelines, among other things

  • Leading face-to-face meetings or teleconferences with regulatory authorities on behalf of clients

  • Participation in winning business by: (i) communicating business leads to the consulting business development managers, (ii) interacting directly with potential clients by teleconference to determine client needs and providing an overview of Syneos Health capabilities and resources directly relevant to meeting those needs, (iii) contributing to the development of client proposals by writing the scope of work and budget assessment, and (iv) thought leadership

  • Participating in and managing activities related to department staff operations, such as: interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations; approval for courses of action on salary administration, hiring, corrective action, and terminations

  • Ensuring Standard Operating Procedures are followed for adequate completion of regulatory documents  

  • Reviewing Requests for Proposals (RFPs) and budgeted hours for regulatory deliverables and forwarding issues to the Project Manager or Functional Manager

  • Contributing to process improvement efforts within the Global Regulatory Consulting group; leading meetings to discuss current and future activities in the department

Job Requirements

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

  • An MS or PhD degree in a physical or life science and subsequent practical experience (e.g., post-graduate experience in discovery and/or applied sciences)

  • At least 7 years of experience in biopharmaceutical development and/or regulatory affairs relating to Chemistry, Manufacturing and Controls, including but not limited to, extensive knowledge and application of:

    • FDA statute, regulation and guidance

    • Product and process analytics, specifications, comparability, stability

    • Product and process risk assessment and quality by design

    • Quality Control and cGMP

  • Demonstrated, independent authorship of CMC regulatory documents accepted by regulatory authorities

  • An attention to detail and a desire to research, gain and apply knowledge for new product classes and/or regulatory issues

  • Supervisory and/or project management experience

  • Experience with biologics/biosimilars development and regulatory affairs

  • Experience or familiarity with document preparation and/or publishing systems (preferred)

  • Ability to travel up to 25% 

 

Full Syneos Health benefits, which include:

  • Competitive compensation and bonus

  • Generous paid time off and company paid holidays

  • Comprehensive medical, dental, and vision package

  • Matching 401(k)

  • Dedicated training and support

  • Referral bonuses and other personalized quality of life conveniences

 

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/Veterans/Disabled).

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