Mgr, Clinical Operations (Regulatory) at Syneos Health – Life Sciences
About Syneos Health – Life Sciences
Syneos Health is a leading provider of fully integrated end-to-end clinical and commercial solutions that bring together deep therapeutic knowledge, superior trial delivery capabilities, and unmatched global scale to help clients bring therapies to market faster and more efficiently.
Job Summary
Primary point of contact for clinical trial related regulatory affairs in India. Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned areas including Site Activation. Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met.
Job Responsibilities
- Contributes to planning for regulatory submissions in assigned country/project.
- Responsible for day to day management of assigned projects.
- Ensure investigational product labels are updated, timely implemented, and maintained in accordance with local regulatory requirements.
- Review and approve regulatory submission packages ensuring their compliance with local regulations and internal guidelines.
- Ensure that best efforts are provided to get timely regulatory approvals of initial and maintenance submissions and all risk mitigation plans are in place to avoid any undue risk to business.
- Ensure regular tracking of regulatory submissions and approvals.
- Line management responsibilities for staff members.
- Acts as a representative of the company with regulatory authorities including face to face meetings.
- Supports business development, including generation of repeat business from existing clients and proposal development.
- Lead the compliance of the clinical trial registration database.
- Monitors personal utilization and utilization of direct reports.
- Acts as a key point of contact for regulatory activities for clients.
- Provides regulatory strategic and operational advice to Company associates and clients.
- Conducts regulatory research and due diligence on projects as needed.
- Arranges, leads, and reports on client and regulatory agency meetings.
- Acts as a resource for technical knowledge.
- Participates in quality improvement efforts to increase overall operational efficiency.
- Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
- Develops solutions to complex problems.
- Provides internal training in appropriate areas of expertise to other departments.
Qualifications
- Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required.
- Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements
- Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- Strong time management, technical and organizational skills. Ability to work independently and within a team environment.
- Knowledge of basic financial concepts as related to forecasting and budgeting. Understands project budgets.
- Must demonstrate good computer skills and be able to embrace new technologies
- Ability to travel as necessary (up to 25%)
Keywords:
Mgr, Clinical Operations, Regulatory, Syneos Health, Life Sciences, Clinical trial, India, Site Activation, Regulatory affairs, GCP, ICH guidelines, Leadership, Contract research organization, Pharmaceutical, Biotechnology, Communication, Presentation, Interpersonal, Change management, Time management, Organizational, Financial, Technology, Travel
