We are looking for an Associate Director, CMC to join our A-team. As an Associate Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products.
Requirements
- Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
- Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development
- Guides the writing of regulatory/scientific documents written by other project team members
- Has advanced scientific knowledge of HA Regulatory Guidance and Regulations
- Interacts with various HAs, including leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, and preparing responses to inquiries
- Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on scientific aspects
- Has advanced understanding of electronic common technical document (eCTD) format and requirements of regulatory submissions
- Prepares product development plans and/or strategies from early development through Phase 4
- Provides strategic advice in evaluating impact and necessary filing requirements and strategies for drug product post-approval changes/variations
- Actively supports staff learning & development within the company
- Provides guidance and advises Project Leads, and/or Project Teams
- Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources
- Manages projects as a Consulting Technical Lead as assigned
- Leads and/or participates in meetings with clients
- Provides mentorship to team members
- Acts professionally with peers and clients, knows business etiquette
Benefits
- Comprehensive benefits package
- Competitive salaries
- Departmental Study/Training Budget
- Flexible Working hours
- Opportunity for remote/hybrid working
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training and internal platforms
- Eligibility for our Spot Bonus Award Program
- Eligibility for our Loyalty Award Program
