Description
We have an opening for a junior Regulatory Affairs specialist to support preparation of CMC regulatory documentation and contribute to global regulatory submissions and strategies.Major Activities:
- 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 lifecycle.
- Prepare CMC responses to health authority questions during development, registration and product lifecycle.
- .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 po-tential authoring issues that may impact submission quality or timelines, as early as possible.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
- Establish and maintain sound working relationships with partners and customers.
- Assume activities in support of the general department such annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
Requirements:
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
1.Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
2.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.
3.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
4.Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
5.Effective planning, organizational and interpersonal skills.
6.Reasonable approach to risk assessment.
7.Excellent written/spoken communication and negotiation skills.
8.Computer literacy.
Please call Beata Klecz on
Michael Bailey International is acting as an Employment Business in relation to this vacancy.