Job SummaryThe incumbent provides strategic leadership and oversight of a regulatory affairs team responsible for the preparation and submission of applications for the assigned product portfolio across all dosage forms, for products developed and/or manufactured internally or through external partners, supporting the United States and Canadian markets. This role drives regulatory strategy, ensuring timely and compliant preparation, submission, and approval of dossiers to the FDA and Health Canada, while navigating complex regulatory frameworks and evolving guidance. The Director partners externally with development partners and internally, cross functionally with R&D, clinical, quality, manufacturing, and commercial teams to align regulatory objectives with business goals, proactively identify and mitigate regulatory risks, and support successful product submissions, approvals and launches, and subsequent transfer of the product to the product life cycle management (PLCM) department. In addition, the role is accountable for talent development, resource planning, and fostering a high performance regulatory organization that delivers high quality submissions on time and in compliance with applicable regulations.
Job Responsibilities- Accountable for establishment and oversight of the New Product Development Regulatory strategy for the assigned product portfolio (all dosage forms; internally and/or externally developed/manufactured) for the US and Canadian Markets.
- Leads the development and implementation of competitive and innovative regulatory strategies to ensure regulatory approval and ongoing compliance.
- Oversees a team responsible to provide high quality regulatory submissions for products in the assigned portfolio and delivering them through to approval and launch, as well as supporting their transition to the product life cycle management team post-launch. This includes identification, and risk mitigation for potential deficiencies.
- Partners with senior leadership and key stakeholders in the identification and analysis of Regulatory policy and emerging trends to inform business decisions and support product portfolio selection.
- Develops and maintains effective relationships while partnering with external vendors, suppliers, business partners and all stakeholders, to ensure the success of the assigned portfolio.
- Leads the development and enhancement of Regulatory knowledge and expertise to support product development and ensure the commercial success of the assigned portfolio.
- Provides an expert level of guidance to support the resolution of complex regulatory issues through creative, yet compliant approaches and in collaboration with relevant stakeholders.
- Accountable for leading communications, meetings, and negotiations with Regulatory agencies, to secure clearances and approvals on relevant project portfolio.
- Leads the ongoing evaluation of existing processes, determines appropriate KPIs, ensures compliance with departmental budgets, and maintains operational metrics to meet business priorities and targets.
- Participates and leads performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee's progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
- Utilizes open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
- Creates a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
- Utilizes networks to attract and hire talent in a comprehensive, differentiated, and consistent manner essential to our continued growth; then, onboards new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
- Ensures adherence of team members (direct reports) with all compliance programs and company policies and procedures.
- All other duties as assigned.
Job Requirements- Education
- Minimum BSc degree or equivalent in Chemistry or Pharmacy or Life Sciences.
- Knowledge, Skills, and Abilities
- Understanding of the development process of multiple dosage forms including solids, semi-solids, sterile parenterals, sterile and non-sterile liquids, as well as small molecules, peptides and biologics/biosimilars, as applicable to assigned portfolio.
- Advanced level of understanding of Global Pharmaceutical Regulatory requirements (in particular for Canada and the US).
- Excellent oral/written communication, leadership, organizational and interpersonal skills.
- Experience
- Minimum ten years' experience in the pharmaceutical industry with five to seven years' experience in a management role
- Minimum of 5 years leadership experience in Regulatory Affairs
- Demonstrated experience in developing strategic partnerships with internal and external partners.
