Director of Internal Audit overseeing asset management audits for Sun Life’s SLC Management portfolio. Leading audit projects and fostering high - performance team development while enhancing stakeholder relationships.
About the role
- Senior Director, CMC at Allucent leading end-to-end CMC strategy for biopharmaceutical development. Responsible for regulatory excellence and managing direct reports in a hybrid work setting.
Responsibilities
- Lead the end-to-end CMC strategy for drug substances, drug products, and analytical development, from early assessment through regulatory submission and commercial launch, with a focus on scientific aspects.
- Promote regulatory excellence by authoring and reviewing CMC dossiers, managing communications with health authorities, and ensuring compliance with FDA, EMA, and ICH guidelines.
- Prepare product development plans, from early development through Phase 4.
- Manage and lead direct reports through development and performance management, and provide training on current and new regulatory requirements.
- Perform other scientific duties as needed.
Requirements
- Bachelor's degree, PharmD, Master's degree, PhD or equivalent in a scientific field, with equivalent professional experience in drug, biologic, or medical device development.
- Advanced scientific and regulatory knowledge in drug, biologic, or medical device development.
- Experience with products in the pre-approval stage; strong experience with biologics is required.
- Experience managing teams is required.
- Prior experience in a CRO is an asset.
- Critical thinking and analytical skills, financial acumen, ability to influence and lead teams, risk assessment skills, and excellent written and verbal communication skills in English.
- Strong computer skills, including SharePoint, Word, Excel, and PowerPoint.
- Quality-focused.
- High emotional intelligence, customer-focused leadership, and strong decision-making abilities.
- Innovative, creative, and pragmatic mindset, including problem-solving skills.
- >10 years of directly relevant post-degree experience in drug, biologic, or medical device development preferred.
Benefits
- Comprehensive benefits package per site
- Competitive salaries per site
- Departmental budget for studies/training to support professional development
- Flexible working hours (where reasonably practicable)
- Option to work remotely/in a hybrid model depending on the site
- Leadership and mentoring opportunities
- Participation in our sponsorship program as a new or existing employee
- Opportunities for internal mobility and career progression
- Financially attractive internal employee referral program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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