Labeling Process Manager- Intagras

Syneos Health, Inc.; Montreal; On-site; USD 71,000 - 140,000; Full time

Job summary

An established industry player is seeking a skilled professional to lead regulatory submissions and project management. This role is pivotal in ensuring compliance and excellence in the biopharmaceutical field. You will collaborate with diverse teams to drive innovative solutions that enhance patient outcomes. With a focus on personal and professional development, this opportunity allows you to thrive in a supportive environment that values your unique contributions. Join a passionate team dedicated to making a difference in the healthcare landscape, where your work truly matters and has a global impact.

Benefits

Company car or car allowance

Health benefits (medical, dental, vision)

401k company match

Employee Stock Purchase Plan

Commissions/bonus eligibility

Flexible paid time off (PTO)

Sick time

Qualifications

• BS degree in a science-related field or equivalent experience required.
• Demonstrated experience in regulatory submissions is essential.

Responsibilities

• Manage project teams and regulatory submissions effectively.
• Provide strategic advice and conduct regulatory research as needed.

Skills

Regulatory submissions

Project management

Interpersonal skills

Communication skills

Analytical skills

Problem-solving

Budgeting skills

Microsoft Office Applications

Education

BS degree in science-related field

Equivalent experience in regulatory/medical writing

Job description

Updated: February 11, 2025
Location: Canada-North America - CAN-Client-Based
Job ID: 25001752

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 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, including interviewing, selection, job description preparation, professional development, goal setting, performance management, coaching, mentoring, employee counseling, and separations.
• 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.
• 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 an industry leader in Regulatory by attending and speaking at industry events, authoring articles for trade journals, and participating in industry associations.
• Develops solutions to complex problems.
• Provides internal training in appropriate areas of expertise to other departments.

Qualifications

What We’re Looking For

• 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.
• Demonstrated experience in contributing to the preparation of regulatory submissions including IND, PMA, NDA, MAA, and CTD, including electronic submissions.
• Comprehensive regulatory knowledge and understanding of pharmaceutical and/or medical device product development.
• Excellent interpersonal and communication skills, including 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 proactivity.
• Strong analytical skills with 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.

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 (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.

The annual base salary for this position ranges from $71,820 to $139,600. 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.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered. The Company will determine what constitutes equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. Together we share insights, use the latest technologies, and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We