Regulatory Consultant (CMC experience within LATAM or APAC region required)

Syneos Health, Inc.; Canada; Remote; CAD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Regulatory Consultant with expertise in CMC, particularly in LATAM or APAC regions. This role involves executing Lifecycle Management strategies, reviewing regulatory submissions, and collaborating with multidisciplinary teams to ensure compliance with global regulations. The ideal candidate will possess a strong background in science or regulatory affairs, excellent communication skills, and the ability to manage multiple projects effectively. Join a passionate team dedicated to changing lives through innovative biopharmaceutical solutions and enjoy a culture that values diversity and personal development.

Benefits

Career Development Opportunities

Supportive Management

Peer Recognition Programs

Total Rewards Program

Qualifications

• Experience in regulatory submissions including IND, PMA, NDA, MAA, and CTD.
• Excellent written and verbal communication skills.

Responsibilities

• Execute commercial Lifecycle Management strategy and submissions.
• Review CMC sections of regulatory submissions and manage day-to-day activities.

Skills

Interpersonal Communication

Analytical Skills

Customer Service

Adaptability

Attention to Detail

Initiative

Education

BS or PhD in Science-related Field

Experience in Regulatory/Medical Writing

Tools

Microsoft Office Applications

Job description

Regulatory Consultant (CMC experience within LATAM or APAC region required)

Updated: January 14, 2025
Location: Canada-North America - CAN-Home-Based
Job ID:25001075

Regulatory Consultant (CMC experience within LATAM or APAC region required)

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.

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

For non-complex and complex submissions, independently fulfill the following responsibilities:

• Execute commercial Lifecycle Management (LCM) strategy and submissions
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Works with regulatory colleagues in development of global regulatory CMC strategies and submissions
• Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
• Act as a subject matter expert and help the team members with day-to-day troubleshooting activities, presenting solutions to project-related problems.
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
• Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
• Prepare training materials and share best practices in the regulatory area, both internally and externally.
• Participate as regulatory support in internal or external project audits.
• Participate as regulatory support on internal cross-functional initiatives.
• Contribute to the creation and/or maintenance of SOPs and other process-related documentation as required.
• Provide support in oversight to team members in the execution of their project responsibilities.
• Capable of identifying when to ensure line support required to provide additional guidance and direction.
• Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

Qualifications

What we’re looking for

• BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience.
• Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.
• 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 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.