REGULATORY AFFAIRS MANAGER (H/F)

Position Title: Head, Regulatory Affairs, Chemistry and Manufacturing Controls (CMC), Specialty Care and General Medicine, Canada
Regulatory Affairs
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.
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. 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
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
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
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
Building effective teams
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
~ 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
Sanofi is an equal opportunity employer committed to diversity and inclusion. Accommodations for persons with disabilities required during the recruitment process are available upon request.
#You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.