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 Regulatory Affairs Manager serves as the primary regulatory contact for clients with responsibility for managing regulatory timelines and resources to achieve client deliverables on time and within budget. S/he represents the Company Regulatory Affairs on project teams both internally and externally; works closely with senior Regulatory staff to plan, prioritize and coordinate regulatory document preparation and submission based on applicable global regulations. Working closely with Regulatory Affairs senior management assumes a leadership role in the research, development, vendor management and implementation of electronic regulatory submissions capability for client documents and applications. Additionally, s/he identifies the need for Regulatory Affairs standard operating procedures (SOPS), guidelines and work instructions, assists with their preparation and with staff training.
Specific tasks would include:
- Serves as the primary contact for regulatory clients.
- Represents Regulatory Affairs on internal and external project teams.
- Manages the established timelines to achieve client deliverables on time and within budget.
- Anticipates areas with the potential to jeopardize regulatory timelines and identifies solutions.
- Manages the submission process which includes editing, publishing, assembly, quality, and tracking documentation to ensure the planned regulatory submissions are progressing in a timely manner.
- Contributes to the review, implementation, and maintenance of the submission process and provides suggestions for ongoing process improvement.
- Assists with assimilation and dissemination of regulatory intelligence by monitoring the global regulatory environment and providing regulatory information summaries to internal and external customers.
- Serves as administrator for clients for hosting EMEA and Clinicaltrials.gov.
- Researches, develops, and/or reviews SOPs, guidelines, and work instructions to ensure compliance.
- Will assist senior management in key aspects of the research, development and implementation of electronic regulatory submissions and interactions with outside vendors.
- Helps prepare for, and participates in, client and regulatory authority audits and inspections.
- Works to build contacts within the regulatory community.
- Collaborates with other departments on new initiatives and process improvements, as requested.
- Provides operational and technical guidance and direction to colleagues; coaching and training to lower level personnel.
- May perform supervisory responsibilities for lower level personnel; includes providing guidance, direction and training on tasks to be performed as well as timekeeping and performance management responsibilities.
What You'll Bring
- Bachelor's degree in business, life sciences or related field of study and 5+ years Regulatory Affairs experience in the pharmaceutical industry / Clinical Research Organization, or equivalent combination of studies and relevant work experience inclusive of substantial experience in researching, reviewing, and processing regulated documents and the demonstrated ability to provide guidance and direction to others effectively.
- A working knowledge base of global regulation of investigational and marketed medicinal products including international and national regulations and guidelines, depending on regional responsibility (e.g. European, US and Canadian regulations/guidelines)
- Ability to evaluate regulations and electronic processes and requirements
- Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, Outlook.
- Highly effective verbal and writing skills; English + local language, if relevant. Knowledge of local language is mandatory for submissions/correspondence with authorities and Ethics Committees. Proficiency in secondary language desirable
Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, colour, 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.