Regulatory Consultant
1 week ago
About the Role
We are seeking a highly skilled Regulatory Consultant to join our team at Syneos Health. As a key member of our regulatory affairs team, you will be responsible for contributing to the planning and preparation of regulatory submissions in assigned regions/countries/projects.
Key Responsibilities
- Contribute to the preparation of regulatory submissions, including IND, PMA, NDA, MAA, and CTD.
- Manage day-to-day activities of project teams and projects.
- 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 proposal development and client communication.
- Develop, review, and monitor project budgets and 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 regulatory documents, including IND and product registration dossiers, clinical reports, and other regulatory documents.
Requirements
- BS degree 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.
- Comprehensive regulatory knowledge and understanding of pharmaceutical and/or medical device product development.
- Excellent interpersonal/communication skills, including 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 pro-activity.
- Strong analytical skills, good attention to detail.
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
- Fluent in speaking, writing, and reading English.
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why 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. Why? 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.
Benefits
The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
The annual base salary for this position ranges from $71,820 to $139,600. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
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