Lead Regulatory Affairs (CMC)

Job type: Full-Time
Accepting BioReady™: Yes
Category: Regulatory Affairs
Education: Bachelor
Experience: 4-6 Years
Employer: Sanofi
Location: Mississauga, ON
Posted: January 14, 2022
Closes: February 14, 2022

Job description:

About Genzyme, a Sanofi Company

Sanofi Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day.  Sanofi Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Sanofi Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.sanofigenzyme.com.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Position Summary:

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 (sanofi-aventis) and Specialty Care [Sanofi Genzyme (SG)] portfolios, through the efficient management of CMC processes and resources.

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

Key Responsibilities:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Key Requirements:

  • Minimum Bachelor’s degree in any relevant science related field (e.g. chemistry, biochemistry, pharmaceutical sciences).
  • 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.
  • 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.
  • MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat.

Languages:

  • English : Advanced – Excellent knowledge.
  • French is an important asset.

Travel:

  • Occasionally.

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.

Thank you in advance for your interest.

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