Mgr, Regulatory Consulting

**Description**

Here at Syneos Health we are currently recruiting for a** Manager, 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.
- Responsible for day-to-day management of project teams and projects, delivering as per agreed KPI’s.
- Contributes to planning for regulatory CMC submissions in assigned region/country/project.
- Conducts regulatory research on projects as needed.
- Manages project teams and preparation of regulatory submissions for conduct of product registrations, and post approval maintenance activities.
- Acts as a representative of the regulatory CMC department with other departments.
- Acts as a resource for technical knowledge.
- Provides strategic and operational advice to clients, including risk evaluation and issue resolution.
- Arranges and leads client meetings.
- Participates in quality improvement efforts to increase overall operational efficiency.
- 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, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. 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.
- Monitors personal utilization and utilization of direct reports.
- Supports business development, including generation of repeat business from existing clients and proposal development.
- Contributes to the building of 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, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
- Provides 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.
- Minimum 9 years’ experience in regulatory CMC discipline preferred.
- 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.
- 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 pro-activity.
- Strong analytic