Dir, Regulatory Consulting (CMC)

Description

Director, Regulatory Consulting

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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 responsibilities

• Provides strategic and tactical regulatory guidance relating to global drug development.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Facilitates communication with clinical staff, subject experts, medical writers, project manager, and team members with respect to technical sections of regulatory documents. Provides regulatory review guidance. Helps to resolve any sponsor/investigator issues with regard to technical and non-technical issues.
• Ensures Standard Operating Procedures are followed for adequate completion of regulatory documents. Reviews and approves guidelines for document preparation. Ensures regulatory documents are accurate and current.
• Leads and attends project staff meetings, project team meetings and training sessions.
• Provides timely, accurate information to business management staff regarding hours to be budgeted for assigned regulatory tasks for Requests-for-Proposal (RFP). Reviews RFPs and budgeted hours for regulatory deliverables and forwards issues to the Project Manager or Functional Manager. Periodically reviews project expenditures for compliance with budgets for assigned tasks.
• Interacts directly with customers and potential customers to explain regulations surrounding assigned regulatory functions; reviews processes and factors affecting project cost estimates.
• Contributes to regulatory affairs process improvement efforts. Leads meetings to discuss current and future activities of the department.
• Maintains overall awareness in the field of drug development, as well as applicable regulatory requirements, by reading related literature, attending training classes, attending professional meetings, etc. Conducts Continuing Education sessions, presenting information gathered from off-site conferences to coworkers.

Other Responsibilities:

• Performs other work-related duties as assigned. Moderate travel may be required (up to 50%).

Qualifications

What we’re looking for

• BS degree in the science/health care field or equivalent combined education and experience. MD or PhD preferred.
• Extensive regulatory experience and significant supervisory and/or project management experience.
• Demonstrated expertise in at least one area of product development: chemistry, manufacturing, and controls development, non-clinical development, or clinical development.
• Experience/familiarity with document preparation and regulatory submission strategies preferred.
• Knowledge of procedures for overall drug development procedures.
• Extensive knowledge of Regional regulatory guidance, regulations and terminology.
• Strong organizational, presentation, documentation, and interpersonal skills as well as a team-oriented approach.
• Proficiency in Microsoft Office Suite and email.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Ability to coach and develop others, and to act as a catalyst for positive change.

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 .

US Only Salary Range - At Syneos 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 USD106,830 to USD207,800. T he 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.

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.

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.

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