Regulatory Consultant CMC - Small Molecule

Syneos Health, Inc.; Toronto; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Regulatory Consultant CMC - Small Molecule to support regulatory submissions and compliance in Toronto, Ontario. The role requires experience with CMC in Biologics, proficiency in Veeva Vault RIM, and ability to work during EST hours. You will manage regulatory activities, contribute to multidisciplinary teams, and ensure adherence to global regulatory standards. The company values diversity and offers a supportive work culture.

Benefits

Career development opportunities

Supportive management

Training programs

Qualifications

• Experience in CMC with Biologics is essential.
• Familiarity with Veeva Vault RIM is required.
• Ability to work during EST hours.

Responsibilities

• Conduct research for regulatory submissions.
• Prepare submissions and conduct agency interactions.
• Manage regulatory activities for assigned projects.
• Support multidisciplinary project teams.
• Act as a subject matter expert.
• Prepare estimates for regulatory services.
• Ensure compliance with regulations and internal policies.
• Conduct training and prepare best practices.
• Participate in project audits and cross-functional initiatives.

Skills

CMC with Biologics

Veeva Vault RIM experience

Job description

Regulatory Consultant CMC - Small Molecule

Updated: Today
Location: Toronto, ON, Canada
Job ID:25104641

Description

Regulatory Consultant CMC - Small Molecule

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:

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.

WORK HERE MATTERS EVERYWHERE

Job Responsibilities

• Previous CMC with Biologics is required
• Veeva Vault RIM experience is required
• Open to NA and LATAM - must work EST hours.

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

• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
• Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
• Manage and/or operationalize the delivery of day-today 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 trouble shooting 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.

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.