Junior Regulatory Affairs Manager

Job Purpose:

Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

Major Activities:

The following tasks are to be performed as assigned:

- Author high-quality CMC documentation for 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 life cycle.
- Prepare CMC responses to health authority questions during development, reg-istration and product life cycle.
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.

Education (minimum/desirable):

Minimum: Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.

Experience/Professional requirement:

- 0-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. 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.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.