Head, Regulatory Affairs, Chemistry and Manufacturing Controls (CMC), Specialty Care and Genera[...]

Sanofi US; Toronto; On-site; CAD 125,000 - 181,000; Full time

Job summary

A biopharmaceutical company is seeking a Head of Regulatory Affairs for their Toronto office. The individual will lead a team in managing Chemistry, Manufacturing & Controls and ensuring compliance for product development. The ideal candidate will have a Bachelor’s degree in a relevant field and at least 5 years of experience in CMC Regulatory Affairs. Strong leadership, communication, and project management skills are essential for success in this role.

Benefits

Health and wellbeing benefits

Competitive salary

Opportunities for growth and development

Qualifications

• At least 5 years of experience in CMC Regulatory Affairs.
• Extensive experience and knowledge of pharmaceutical research and development processes.
• Knowledge of the regulatory environment.

Responsibilities

• Provide leadership to regulatory CMC professionals.
• Ensure quality and timely preparation of submissions.
• Maintain compliance with CEPA and other regulations.
• Network with key partners and corporate regulatory sites.

Skills

Excellent knowledge of Regulatory Affairs

Leadership and managerial skills

Strategic agility

Building effective teams

Excellent communication skills

Strong decision-making skills

Excellent negotiation skills

Strong Project Management Skills

Good risk analysis skills

Education

Bachelor’s degree in relevant science

Tools

MS Outlook

PowerPoint

Word

Excel

Adobe Acrobat

Job description

Reference No. R2832279

Position Title: Head, Regulatory Affairs, Chemistry and Manufacturing Controls (CMC), Specialty Care and General Medicine, Canada

Department: Regulatory Affairs

Location: Toronto, ON

About the Job:

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

The primary purpose of this position is to provide leadership to a team of regulatory CMC (Chemistry, Manufacturing & Controls) professionals. Specifically, the position supervises the successful execution of product development and regulatory compliance activities pertaining to CMC throughout the product lifecycle for all development and marketed products in the General Medicine and Specialty Care portfolios (sanofi-aventis), through the efficient management of CMC processes and resources.

This position may also be a designated back-up to the Head, Regulatory Affairs.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

1) Accountable for the activities of a team of professional level individuals, that cover all development and marketed products (80-90% of allocated time)

• A) Regulatory Activities and Resources (60% of allocated time):
• Assure optimal Canadian regulatory input into the Global RA CMC working groups in line with strategies defined for Canadian RA
• Provide leadership and managerial support to CMC submissions teams to ensure quality decisions and timely preparation of submissions in order to achieve the shortest time to approval and the target CMC profile
• Planning and coordination of all submissions involving a CMC component within agreed timelines
• Ensure that the content of technical documents needed to support RA CMC submissions complies with Canadian standards.
• Assure the accuracy of all CMC information contained within regulatory documentation authored by the RA CMC team
• Assess and assure adequate reporting to necessary authorities as per current regulatory and legal requirements for CMC changes
• Ensure compliance to CEPA (Canadian Environmental Protection Act) and timely filing of New Substances Notification
• Ensure team maintains compliance (as per Global Regulatory Affairs performance timelines) to provision of current and accurate data in internal database systems
• For the evaluation of new business opportunities and due diligence, provide CMC scientific advice and assessment
• As part of RA Leadership team, assist Head, Regulatory Affairs in setting strategic direction for team and ensuring smooth daily operations
• Regulatory Resources:
  • Support the development of CMC expertise of employees in the Regulatory Affairs team
  • Maintain awareness and knowledge of new and emerging local and international (EU,US, ICH) regulatory trends as well as on basic regulatory safety and efficacy Canadian requirements
  • Review and provide comments on CMC related HC draft guidelines and policies

B) Development of Human Capital (20-30% of allocated time):

• Direct Reports:
  • Ensure implementation of departmental vision and strategies into individual priorities and goals
  • Provide constructive feedback and coaching to all direct reports on an ongoing basis to facilitate and enable the attainment of employees’ development plans
  • Complete performance review activities for all direct reports as per the established corporate guidelines and practices
• Self-Development:
  • Elaborate and implement a personal development plan that will allow for the attainment of personal goals and required competencies aligned to the corporate values and priorities

2) Networking (10-20% of allocated time)

• Establish and maintain a network with the key corporate regulatory sites and business units to assure the successful execution and alignment of Canadian-specific strategies within an international corporate context
• Develop, optimize and maintain a network with key partners including the Canadian regulatory authority and key opinion leaders and seize opportunities to negotiate improved regulatory processes with the Canadian authority
• Act as Sanofi liaison to industry advocacy external groups such as BIOTECanada or Innovative Medicines Canada (IMC), as required

About You:

Education:

• Minimum Bachelor’s degree in any relevant science related field (e.g. chemistry, biochemistry, pharmaceutical sciences)

Experience:

• At least 5 years of experience in CMC Regulatory Affairs, as a project leader; extensive experience and knowledge of pharmaceutical research and development processes and of the regulatory environment

Specific Skills and/or Competencies

• Must have Excellent knowledge of Regulatory Affairs, more specifically in the field of CMC
• Leadership and managerial skills
• Strategic agility
• Building effective teams
• Excellent communication skills
• Strong decision-making skills
• Excellent negotiation skills
• Strong Project Management Skills
• Good risk analysis skills

Languages

• English (written and spoken)
• French is an important asset

Computer Knowledge

• MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat

Travel

• Occasionally

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

This position is for a new vacant role that we are actively hiring for.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

#GD-SG #LI-GZ #LI-Onsite

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, in different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

North America Applicants Only

The salary range for this position is:

$125,300.00 - $180,966.66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link.

La fourchette salariale pour ce poste est la suivante:

$125,300.00 - $180,966.66

Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociau de l'enterprise. Des informations supplémentaires sur les avantages sont disponibles via le lien.