|State ||North Carolina [NC]|
|Title ||Regulatory Consultant|
|Job ID ||69469|
|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 developed and commercialized. 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 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 ||In this role, you will 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. You will:|
- Develop consulting deliverables and conduct project delivery activities to ensure consulting engagements are delivered in line with contracted services and to the satisfaction of the customer. This includes engagement in project planning, management of primary and secondary research and quantitative and qualitative analyses, and communicating results.
- Conduct research of existing product data and published literature 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.
- Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
- Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development 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 and on internal cross-functional initiatives.
Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
- A Bachelor s Degree or PhD, 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, PMA, NDA, CTA, MAA, and CTD, including electronic submissions.
- 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.
- The ability to interact with staff from multiple departments and offices to establish project standards.
- The ability to travel up to 25%
- The drive for self-development, the ability to collaborate, and an action-oriented work ethic
Full Syneos Health benefits which include
- Generous paid time off and company paid holidays
- Comprehensive medical, dental, and vision package
- Matching 401K
- 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)
|Position Type/Category ||Compliance/Regulatory|
|Recruiting Area ||Corporate Direct|
|Employment/Job Type ||Full Time|
|Employment Type ||Syneos Health position|