Description

Regulatory Affairs Associate Director

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.

JOB SUMMARY

Responsible for the development of regulatory submissions and post marketing regulatory support for clients. This includes authorship of portions of regulatory submissions, regulatory writing, regulatory research, and ensuring compliance with relevant guidelines and standards. Responsible for providing advice and assistance to clients and other associates in areas of expertise and may manage smaller client projects. Supports new business development in area of expertise.

Job responsibilities

*         Responsible for day-to-day contribution to project teams and projects.

*         Acts as a representative of the GRAS regulatory department with other departments.

*         Contributes technical expertise to proposals and assists with Business Development initiatives.

*         Understands project budgets, scope of projects, allocated hours, and tracks compliance.

*         Interacts with internal and external personnel, clients, and technical experts on projects.

*         Conducts regulatory research on projects as needed.

*         Provides operational advice to clients.

*         Prepares consulting reports under guidance.

*         Arranges, leads, and reports on client meetings.

*         Contributes to regulatory agency meetings.

*         Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions.

*         Prepares full regulatory submissions for INDs, product registrations, and post approval maintenance activities, and participates on project teams.

*         Acts as a resource for technical knowledge.

*         Participates in quality improvement efforts to increase overall operational efficiency.

*         Contributes to the building of the regulatory systems and infrastructure needed for GRAS.

*         Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees.

*         Provides internal training in appropriate areas of expertise to other Departments.

*         May act as a Line Manager to a small team, dependent on the location.

Other Responsibilities:

Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications

What we're looking for

*         BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. PhD preferred.

*         Moderate regulatory, pharmaceutical/medical device related experience.

*         Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.  Experience in niche submissions such as ODD, PIP/PMP an advantage.

*         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 skills.

*         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.

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information:
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 has a voluntary COVID-19 vaccination policy.  We strongly encourage all employees to be fully vaccinated.  Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees.  These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.

AtSyneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.  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 $60,930 to $115,100.  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.