Regulatory Affairs Specialist, CMC

ICON is currently recruiting for a Regulatory Affairs Specialist, 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.

Regulatory Affairs Specialist

Reporting to the Principal Consultant, Regulatory CMC, the Regulatory Affairs Specialist will provide Regulatory CMC services to clients within the pharmaceutical and biologic regulatory services environments in Canada, US, and Europe. This will include CMC support for assessment, preparation, compilation and submission of CTA/IND/(Q)IMPD, DMF, marketing authorizations, variations/ lifecycle submissions, renewals, and agency briefing documentation.

Responsibilities:

·         Support Director/project teams in the preparation of the CMC sections of all submission types in adherence with applicable legislation, regulations and guidelines, facilitating approvals and continued client compliance.

·         Review CMC sections of client prepared submissions and prepare gap analyses detailing requirements for submission to different jurisdictions.

·         Monitor and manage project-specific logs, email accounts, incoming written communications and telephone calls.

·         Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.

·         Peer review documents prepared by other professionals within the CMC Regulatory team.

·         Liaise with other strategic regulatory teams (e.g. regulatory affairs, e-publishing colleagues) to ensure consistent, accurate and quality documentation is provided to client and agencies.

·         Identify issues and address them in a timely manner, including preventive actions.

·         Be able to liaise with and advise clients on the process and timelines, changes to the regulations as required ensuring timely and quality delivery of projects.

·         Assist in the development of assessments and strategic regulatory plans for client product development programs.

·         Plan and track designated project activities including financial tracking under supervision.

·         Other duties as assigned.

Qualifications:

·         Bachelor’s degree in chemistry, chemical engineering, biochemistry, biology or life sciences

·         Minimum 3 years’ experience in Regulatory Affairs in the pharmaceutical/ biopharmaceutical industry, with emphasis in CMC (pharmaceutical industry experience at a production facility is an asset).

·         Good working knowledge of ICH, Canadian US, and /or European drug regulations/guidance as it applies to CMC (knowledge of CMC regulatory guidance in other jurisdictions is an asset).

·         Working knowledge of GMP for active pharmaceutical ingredients and drug product is preferred.

·         Experience with regulatory submission types across the product life-cycle, specifically with Module 3 and 2.3 QOS requirements.

·         Ability to maintain a high level of accuracy and attention to detail.

·         Comfortable working in a fast-paced environment with several projects at one time.

·         Self-motivated and proactive, with good problem solving and negotiation skills.

·         Proficiency in MS-Office applications including Microsoft Word, Excel and PowerPoint.

·         Sound written and oral communication skills, good organizational and planning skills.

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

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