Regulatory Affairs Specialist - CMC
This is a contract position to support existing project in CMC area.
Your responsibilities: 1. Author CMC documentation for Health Authority (HA) submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle. 2. Prepare CMC responses to health authority questions during development, registration and product lifecycle. 3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. 4. Identify content, quality and/or timeliness issues with source documents, or any other po-tential authoring issues that may impact submission quality or timelines, as early as pos-sible. 5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends. 6. Actively participate as a member of the global team by contributing to the regulatory strat-egy, identifying the critical issues and lessons learned. 7. Establish and maintain sound working relationships with partners and customers. 8. support of the general department in tasks related to (Drug Reg Affairs Global Regulatory Compliance System) support, annual and product renewal writing,
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent. Languages: Fluent English required (oral and written). Good skills in site (local) language desired (oral) : Regulatory experience preferred, and/or experience in drug/biopharmaceuticals Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process.
Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload. Effective planning, organizational and interpersonal skills.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.