Regulatory Consulting Manager

hace 2 semanas

Xico, México Syneos Health, Inc. A tiempo completo

Job Summary
At Syneos Health, we are seeking a highly skilled Regulatory Consulting Manager to join our team. As a key member of our regulatory department, you will be responsible for planning and managing regulatory submissions, acting as a representative of the department, and providing regulatory advice to associates.

Key Responsibilities
• Contribute to the planning and management of regulatory submissions in assigned regions/countries/projects
• Manage project teams and projects on a day-to-day basis
• Line management responsibilities for staff members, including interviewing, selection, job description preparation, professional development, goal setting, performance management, coaching, and mentoring
• Act as a representative of the regulatory department with other departments
• Support business development, including generation of repeat business from existing clients and proposal development
• Develop, review, and monitor project budgets; review client invoicing
• Monitor personal utilization and utilization of direct reports
• Act as a key point of contact for clients and regulatory authorities
• Provide regulatory advice to Company associates
• Conduct regulatory research on projects as needed
• Provide strategic and operational advice to clients
• Arrange, lead, and report on client and regulatory agency meetings
• Write IND and product registration dossiers, clinical reports, and other regulatory documents
• Act as a resource for technical knowledge
• Participate in quality improvement efforts to increase overall operational efficiency
• Contribute to the building of regulatory systems and infrastructure needed for GRAS
• Develop a reputation for the Company as an industry leader in Regulatory by attending and speaking at industry events
• Develop solutions to complex problems
• Provide internal training in appropriate areas of expertise to other departments

Qualifications
• BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience
• Demonstrated experience in contributing to the preparation of regulatory submissions, including IND, PMA, NDA, MAA, and CTD, including electronic submissions
• Comprehensive regulatory knowledge and understanding of pharmaceutical and/or medical device product development
• Excellent interpersonal/communication skills, including excellent written and verbal communication skills
• Excellent customer service skills, with the ability to work both as a team member and independently
• Good quality management and budgeting skills
• Good people management, project management, problem-solving, and decision-making skills
• Advanced skills in Microsoft Office Applications
• Ability to interact with staff from multiple departments and offices to establish project standards
• Good initiative, adaptability, and proactivity
• Strong analytical skills, good attention to detail
• Ability to work concurrently on projects, each with specific instructions that may differ from project to project
• Fluency in speaking, writing, and reading English

About Syneos Health
At Syneos Health, we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Why Work at Syneos Health?
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered. Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status.

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