Responsible for management and development of CMC Regulatory Consulting staff as required. Interacts with senior management and staff on operational procedures and processes within the Regulatory department to ensure compliance.
Directs and oversees CMC regulatory aspects of EU-based product development including, but not limited to : advising clients on CMC regulatory requirements in Europe, preparing and reviewing regulatory submissions (such as IMPDs, MAAs, meeting packages, etc.
reviewing client regulatory documents, assisting senior management with administration of the Regulatory Affairs Department, developing work flow, and regulatory records document processes.
Leads CMC-specific discussions with EU regulatory authorities as needed on behalf of Syneos clients.
Supports business development, including generation of repeat business from existing clients and proposal development
QUALIFICATION REQUIREMENTS (please indicate if preferred’)
Along with demonstrated initiative, uncompromising integrity and a results-oriented mindset, the ideal candidate has :
Experience working with small molecule and biologic drug products is desired.
Experience in other regulatory markets is a plus.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.
All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability.
Europe - AUT-Home-Based
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RegularExpected Salary Range : 1