Regulatory and Clinical Affairs Manager - Anywhere, US
Office-based or Remote-based
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
The Manager of Regulatory Affairs is responsible for providing advice on regulatory strategy and support for his/her assigned department and business opportunities for regulatory, clinical, and pediatric strategic development. The Manager of Regulatory Affairs will collaborate with other interdisciplinary leaders and contribute to the overall business plan at both the tactical and strategic level.
Specific tasks would include:
- Represent the company and department externally on relevant occasions as well as attendance of bid defense meetings.
- Build relationships with existing and future clients.
- Ensure execution of cross-functional and global corporate goals.
- Lead clinical strategy through development of the study synopsis with identification and coordination with necessary resources and input from other departments (e.g., biostatistics, medical affairs, pharmacokinetics).
- Provide support and prepare (write, review, edit) regulatory documents including: Pre-IND,IND, NDA/BLAs, FDA meetings, EMA Scientific Advice, EMA Protocol assistance and any general strategic advice needs
- Preparation of Investigational Medicinal Product Dossier (IMPD)
- Generation of protocol concept/synopsis to support clinical development
- Experience in Pediatrics for the following is a plus:
- Generation of pediatric strategy to support PIP and PSPs
- Support client needs nonclinical support (general and pediatric) and formulation development for pediatric development
- Bachelor's or Master's degree with a scientific background and a minimum of 10 years applicable industry experience or equivalent combination of education and experience.
- At least 7 years of management experience.
- Excellent working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Expert knowledge of CRO or consultancy business with emphasis in delivering with a high level of quality, on time, and on budget.
- Proficiency in Microsoft Word, Excel, and PowerPoint, Outlook.
- Effective verbal and writing skills; English + local language, if relevant.
If you're passionate about bringing clinical trials to life, we encourage you to apply today! Please apply online stating your earliest start date/notice period and your desired salary.
Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying.