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.
The Director, Regulatory Strategy, Consulting, & Submissions will be responsible for the management and development of the regulatory management team and staff. You will interact with senior management and staff on operational procedures and processes within the Regulatory department to ensure compliance. You will direct and oversee all regulatory aspects of clinical product development including, but not limited to, preparing and reviewing regulatory submissions (such as INDs, NDAs, IMPDs, CTD, eCTDs), reviewing clinical site regulatory documents, assisting executive management with the administration of the Regulatory Affairs Department, developing work flow, and regulatory records document processes. More specifically, you will:
Provide strategic and tactical regulatory guidance relating to global drug development
Participate in and manage 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. Approve courses of action on salary administration, hiring, corrective action, and terminations.
Facilitate communication with clinical staff, subject experts, medical writers, project manager, and team members with respect to technical sections of regulatory documents.
Ensure Standard Operating Procedures are followed for adequate completion of regulatory documents.
Review RFPs and budgeted hours for regulatory deliverables and forward issues to the Project Manager or Functional Manager.
Interact directly with customers and potential customers to explain regulations surrounding assigned regulatory functions; reviews processes and factors affecting project cost estimates.
Contribute to regulatory affairs process improvement efforts. Lead meetings to discuss current and future activities of the department.
Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
BS degree in the science/health care field or equivalent combined education and experience. MD or PhD preferred.
Extensive clinical research experience and significant supervisory and/or project management experience.
Demonstrated expertise in at least one area of clinical product development: chemistry, manufacturing, and controls development, non-clinical development, or clinical development.
Experience or familiarity with document preparation and/or publishing systems preferred.
Knowledge of procedures for reporting non-clinical and/or clinical study data.
Extensive knowledge of FDA regulations and medical terminology.
Ability to travel up to 50%.
The drive for self-development, the ability to collaborate, and an action-oriented work ethic
Full Syneos Health benefits which include:
Competitive compensation and bonuses
Generous paid time off and company paid holidays
Comprehensive medical, dental, and vision package
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/Vets/Disabled)
Internal Number: 1072
About Syneos Health
Syneos Health is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry-leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries.
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