Regulatory Manager (CMC and Biologics)

Regulatory Manager (CMC and Biologics)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Min of 10+ yrs of Biologics + CMC experience 

Experience in Biologics, Biosimilars, and CMC.

Strong expertise in Regulatory Intelligence across various global markets.

Hands-on experience in Module 3 authoring and dossier preparation.

Knowledge of regulatory submission strategies and compliance requirements.

Extensive experience in product lifecycle management.

Managed both pre-licensing and post-licensing regulatory activities.

Experience in preparing and maintaining regulatory documentation for health authority submissions.

Familiar with market-specific regulatory requirements and change management processes.

Strong understanding of CMC variations, amendments, and renewals.

Open to exploring opportunities in Small Molecules in addition to Biologics and Biosimilars.

JOB RESPONSIBILITIES

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

QUALIFICATION REQUIREMENTS

 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. 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 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 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.

http://www.syneoshealth.com

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.