Regulatory Affairs CMC Manager (m/f/d)

Regulatory Affairs CMC Manager

m / f / d)

Merken Basel Stadt Freelance / temporary employment for a project Reference number : 664194 / 1 Start date : asap Project duration : 18 MM++

My duties

• Support all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects / products
• Identify the required documentation and any content, quality and / or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
• Author and / or review high-quality CMC documentation for Health Authority submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines
• Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
• Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stake holders
• Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate

My qualifications

• Minimum : Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Desirable : Advanced Science Degree
• Fluent English required (oral and written). Excellent written / spoken communication skills
• Working knowledge / experience in regulatory submission and approval processes desirable
• Working knowledge of chemistry / biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines.

Knowledge of the product development and life cycle desirable

• Demonstrated track record to successfully work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects
• Ability to work successfully with global project teams and prioritize activities considering timelines and workload
• Effective planning, organizational and interpersonal skills
• Computer / IT systems literacy

My benefits

International pharma company

About Hays

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential.

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My contact at Hays

Reference number 664194 / 1