Head of Regulatory Strategy

1 week ago

Toronto, Canada Moderna Full time

**The Role**:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.
As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is expanding its impact across Canada, anchoring in Toronto—Canada's largest city known for its vibrant biotech innovation. Our offices in Toronto focus on commercial operations, bringing our innovative mRNA products to the Canadian market. By joining our team, you will be at the forefront of transforming medicine and building a resilient future in biotech and healthcare innovation, contributing to Canada's leadership in global health.
The Head of Regulatory Strategy, Canada, will lead Moderna's regulatory team within the Canadian affiliate. Based in Toronto, this forward-looking role requires a creative and agile regulatory expert to navigate the challenges of advancing mRNA vaccines and therapeutics in Canada. With oversight across therapeutic areas such as Infectious Diseases, Oncology, Cardiovascular, and Rare Diseases, this leader will be pivotal in managing regulatory submissions and interactions with Health Canada.
This role reports to the VP-Regulatory, International, and collaborates with the Canadian General Manager to drive regulatory strategies aligned with Moderna's business objectives.
**Here's What You’ll Do**:Your key responsibilities will be**:
Defining and leading regulatory strategy for assigned projects and jurisdictions in collaboration with local, regional, and global leadership.
Managing and developing regulatory submissions and documents, including NDS, DSURs, PSURs, orphan drug designations, and more.
Ensuring compliance with Canadian regulatory requirements and maintaining necessary business licenses.
Building and leading the regulatory team to meet key milestones and business objectives.
Leading strategic interactions with Health Canada and other regulatory agencies, providing a single point of contact.
**Your responsibilities will also include**:
Supporting commercial execution from a regulatory perspective, including artwork and promotional material reviews and training for local business teams.
Collaborating effectively with cross-functional teams to assess regulatory risks and implement mitigation strategies.
Delivering effective presentations and communications to internal and external stakeholders.
Supporting the broader global regulatory strategy and ensuring alignment with Moderna's business objectives in Canada.
**The key Moderna Mindsets you’ll need to succeed in the role**:
**We act with urgency**: This role requires swift and strategic decision-making to navigate regulatory complexities and deliver innovative therapies to patients.
**We obsess over learning**: The dynamic regulatory landscape necessitates a commitment to staying ahead of emerging trends, regulations, and opportunities to advance mRNA technology.
**Here’s What You’ll Bring to the Table**:
Bachelor’s Degree in Life Science or related discipline; advanced degree preferred (PharmD, MSc, PhD).
10+ years of experience in the pharmaceutical industry. 8+ years of experience in Regulatory strategy.
Strong knowledge of current local (Canada), US, and international regulations related to clinical, nonclinical, and regulatory requirements for innovative medicines.
Solid experience with eCTD and regulatory filings.
Knowledge of and specific experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance in Canada and International countries.
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Ability to work independently to manage multiple projects in a fast-paced environment.
Ability to lead and collaborate effectively in a dynamic cross-functional matrix environment to drive meeting each program’s critical regulatory milestones.
Effectively communicate regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management as relevant.
Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.
Effective collaboration with other line functions within the local affiliate (such as general manager, commercial strategy, policy, pharmacovigilance, quality assurance, etc.); proactive regulatory input and support to the local affiliate’s business activities.
Fluency in English (French is an asset).
A desire to be part of a high-growth, transformational company that is Bold, Re

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