CMC Author

CMC Author- Homebased in UK, Spain, Germany or France

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Senior Manager, Regulatory Affairs CMC to join our diverse and dynamic team. As a Senior Manager, Regulatory Affairs at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing:

•  CMC knowledge - Ideal candidate would author Module 3 CTD documents and participate in strategic discussions and act as RA specialist..

• You will have advance understanding of regulatory work and possess specialist RA CMC knowledge with different modalities (peptides and proteins is highly desirable)
• Be familiar with global requirements in major regions (including but not limited to USA, EU, Japan and China)
• different stages of drug development (including LCM).
• Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices, regulatory intelligence, due diligence, strategic CT support/GCP compliance, biological/biotech/biosimilars, small company support (incl. SOPs development etc.).

Your profile:

• EU/APAC: In-depth proven regulatory affairs expertise. Must have pharmaceutical/CRO industry experience.

• Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.

• Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail.

• Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Are you a current ICON Employee? Please click here to apply