Principal Consultant, Regulatory Affairs, CMC

ICON is currently recruiting for a Principal Consultant, CMC  to join our Strategic Regulatory & Safety Consultancy group that forms part of a wider Commercialization and Outcomes group. Our regulatory consulting team serves clients around the globe—from biotech startups to big pharma—as well as the research firms that serve them. We’re headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 100 professionals and staff.

Job Title: Principal Consultant, Regulatory Affairs, CMC 

Location: Regional (US or EU) or head-office based
Type: Full time, permanent 

• Effectively manage/execute/oversee the preparation of CMC regulatory submission documents, including for clinical trial applications, marketing applications, post-market changes, and scientific advice in adherence with applicable regulations and guidelines for submission to health authorities.

• Review and/or create primary source documents including technical study reports and protocols.

• Author CMC submission documents/reports and/or review client-prepared documents for completeness, accuracy and compliance to regulations.

• Prepare technical assessments of CMC source documentation and responses to client technical questions on document content.

• Prepare or review gap analyses of client prepared regulatory documents detailing requirements for submission to different jurisdictions.

• Facilitate submission approvals and amendments through leading communications and negotiations with clients, health authorities, and project teams, building positive working relationships with clients and health authority contacts.

• Manage project workflow including prioritizing project objectives, and establishing timeframes for projects with clients.  Oversee progress and completion of projects with project team members, ensuring timeframes and deadlines are met.

• Lead and participate in formal interactions (face-to-face meetings, teleconferences, etc.) with clients and health authorities. 

• Develop new business and conduct quote preparation and new project /client consultations.

• Act as an internal resource and mentor for peers, advising on technical and regulatory CMC issues and strategies, based on a deep knowledge of applicable scientific concepts and governing legislation and guidelines.

• Present industry related training seminars or workshops at industry conferences.

• Participate in the planning and execution of the strategic direction for the regulatory CMC business.

• Minimum 10 years regulatory CMC experience, with expert knowledge and understanding of pharmaceutical/biologics product and process, analytical or formulation development.

• Extensive knowledge of regulatory submission types across the product life cycle, specifically with Module 3 and 2.3 QOS requirements, with global dossier preparation experience.

• Experience of Regulatory CMC and product development in US and Europe. Experience in other regions is advantageous.

• Innovative strategic planning and excellent problem solving skills.

• Previous business development/senior consulting experience is an asset.

• Strong knowledge of a variety of computer programs including MS Office, Adobe Acrobat, eCTD compiling software, and electronic document management systems.

The Position:

Reporting to the Divisional Principal, Regulatory CMC, the Principal Consultant, Regulatory CMC provides expert regulatory CMC advice/strategy and opinion to clients. The Director will lead and execute projects, managing regulatory submission documents for biologics and/or small molecules in adherence with applicable regulations and guidelines for submission to Canada, US, EU, and ROW.

Responsibilities:

Provide strategic technical and regulatory support to clients on chemistry manufacturing and control issues for biologic and/or small molecule products.

·         Other duties and responsibilities as assigned.

Requirements:

·         Minimum Bachelor’s degree in chemistry, chemical engineering, biochemistry, biology or life sciences, advance degree is an asset.

·         Self-motivated and proactive, with excellent problem solving, negotiation, organizing and planning skills.

·         Excellent written and oral communication skills, including scientific/technical writing experience.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment

*LI-SB1