Regulatory CMC Associate Manager
Our client is a global pharmaceutical company currently looking for a Regulatory CMC Associate Manager.
- Author high-quality 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.
- 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 potential 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 as Drug Reg Affairs Global Regulatory Compliance System support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions). view of clinical study data for cardiovascular diseases
- Perform ongoing review of clinical data using patient profiles and data listings
- Perform data reconciliation
- Generate and close data queries in OC-RDC system (e-CRF).
Qualifications and Experience:
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent is preferred. Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent is a plus
- Minimum 2 years of Regulatory experience and/or experience in drug/biopharmaceuticals
- 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
- Excellent written/spoken communication and negotiation skills
- Sound knowledge of English is required, good knowledge of German is desired
- Relevant working/residency permit or Swiss/EU-Citizenship required