Associate Director, CMC – Central/Eastern Europe

Role Overview

In this role your key tasks will include:

• 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

Requirements

To be successful, you will possess:

• Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
• Scientific and regulatory knowledge of drug, biologic, or device development
• Critical thinking and analytical skills, as well as strong written and verbal communication skills in English
• Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
• Quality focus
• Emotional intelligence and decision-making skills
• Innovative, creative, and practical thinking including problem-solving skills
• ≥ 10 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable
• You have relevant work experience in a CRO environment, specific experience with small molecule (solid, liquid, oral, topical, injectable (sterile products), inhalation.
• You are hands on and able to author eCTD CMC Module 3.0 focused on pre-approval products.

Benefits

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• 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 in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees