Regulatory Affairs Manager
vor 1 Tag
The Life Science Career Network
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a:
Regulatory Affairs Manager
on a contract of 10 months, with possibility of extension afterwards.
Main Responsibilities:
- Author and review CTD module 3.2 sections (drug substance/ drug product) for biologicals medicinal products;
- Prepare high-quality clinical trials applications, BLA/ MAA, and post-approval submissions;
- Manage timely responses to Health Authority (HA) questions;
- Lead and coordinate activities to ensure submission deadlines are met;
- Communicate and escalate risks and issues to management and project teams, as applicable;
- Act as RA Point of Contact or RA team member for assigned projects;
- Manage change Controls and Deviations;
- Support site-specific regulatory documentation and activities.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- A Bachelor’s or Master’s degree in Biology, Chemistry, Biochemistry, Pharmacy or equivalent;
- At least 5 years in authoring high-quality CMC CTD sections (content and format) for drug substance, drug product, and appendices from first-in-human to post-approval for biological medicinal products;
- Good understanding of manufacturing processes and quality control for biological medicinal products;
- Strong knowledge of CMC requirements for biologics as well as good procedural knowledge (EU and US; other markets is a plus);
- Good CMC writing skills;
- Previous experience in contractor environment e.g. CMO/CDMO, CRO, Consultancy is an advantage.
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.
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