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Mgr, Regulatory Consulting
hace 3 meses
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.
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.
Responsibilities for this role are as follows:
- Contributes to planning for regulatory submissions in assigned region/country/project.
- Responsible for day to day management of project teams and projects.
- 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.
- Acts as a representative of the regulatory department with other departments.
- Supports business development, including generation of repeat business from existing clients and proposal development.
- Develops, reviews, and monitors project budgets; reviews client invoicing.
- Monitors personal utilization and utilization of direct reports.
- Acts as a key point of contact for clients and regulatory authorities.
- Provides regulatory advice to Company associates.
- Conducts regulatory research on projects as needed.
- Provides strategic and operational advice to clients.
- Arranges, leads, and reports on client and regulatory agency meetings.
- Writes IND and product registration dossiers, clinical reports, and other regulatory documents. Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post approval maintenance activities.
- Acts as a resource for technical knowledge.
- Participates in quality improvement efforts to increase overall operational efficiency.
- 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.
- Develops solutions to complex problems.
- Provides internal training in appropriate areas of expertise to other departments.
Other Responsibilities:
- Performs other workrelated duties as assigned. Minimal travel may be required (up to 25%).
Qualifications
- BS degree, preferably in a sciencerelated field or equivalent experience in science/regulatory/medical writingrelated field or moderate pharmaceutical/medical device related experience. Moderate experience in regulatory.
- 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 interperso
