Regulatory Affairs Manager CMC
The Orion Group are currently seeking a Regulatory Affairs Manager (CMC) to work with our multinational Biotechnology client in Cambridge.
- Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
- Manages Strategy and Execution for all regulatory submissions (e.g. clinical trial, variations, extensions and marketing applications) for products in compliance with global filing plans and local regulatory requirements
- Authoring and coordinating responses to questions across assigned products and countries.
- Gathering, consolidating and analysing regulatory intelligence for the EU region and support its application to product-specific activities
- Point of Contact with local country regulatory staff
- Project management of submissions and monitoring status of applications
- Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
- Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
- Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance
- Provides guidance for regulatory assessments of change control requests
- Sets project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments
- Document and communicate details and outcomes of regulatory agency interactions to global regulatory and operations teams and relevant senior management
Knowledge & Experience:
- Regulatory knowledge in regional legislation
- Working with policies, procedures and SOPs
- Experience with national legislation and regulations relating to medicinal products
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
- Understanding of drug development Scientific / Technical Excellence
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.
- In-depth experience of pharmaceutical/biotechnology or medical device industry
- Strong record of related experience within Regulatory Affairs (min 7 years)
- CMC- specific regulatory knowledge & experience within biotechnology
- Direct experience with EU and EM market applications - MAAs or variations
- Good understanding and direct experience of ex US filings
- Creation and execution of regional regulatory strategies - MAAs or variations
- 5-7 years related experience within Regulatory Affairs
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
- "clinical trials"
- "post approval"
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