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REGULATORY AFFAIRS CMC SENIOR MANAGER BIOLOGICS
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REGULATORY AFFAIRS CMC SENIOR MANAGER BIOLOGICS Tasks and Responsibilities- Define CMC regulatory procedures and requirements for Development, Marketing, and Life cycle management for the internal and licensed products as per current legislation autonomously for biological products.
- Prepare and review together with internal stakeholders and external partners/vendors the regulatory CMC documentation required for products under pre-clinical and clinical development stages (e.g. IMPD/IND/documents for interactions with Regulatory Health Authorities) up to product approval (marketing authorisation applications and responses to Health Authorities) and post-approval activities (variations, renewals, line extensions, etc.), ensuring they are presented to partners, market companies, and health authorities within the established deadlines for biological products.
- Participate as CMC regulatory subject matter expert in meetings with internal and external stakeholders.
- Represent Almirall by participating in Joint Committees or joining working teams with partners.
- Monitor regulatory procedures up to final resolution, reporting on the regulatory databases all relevant information and associated documents. Also, inform the organization as per internal procedures to ensure implementation of regulatory changes.
- Monitor the registration status of all products under his/her responsibility and keep the annual schedule updated with all regulatory procedures to be performed.
- Coordinate and supervise global/corporate Regulatory CMC activities carried out for regulatory purposes through consultants, CROs, local agents, and/or partners.
- Provide support to market companies for products that may need it, for planning regulatory procedures, when there is a lack or extra need for occasional regulatory support and representing them in corporate projects. Draw up and maintain the policies and procedures that govern regulatory operations with market companies and partners.
- Evaluate proposed quality regulatory changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of change.
- Supervise the compliance of safety and environmental standards in my area of responsibility, as well as identify situations or actions that may involve a risk in the processes under my responsibility, adopting or proposing the corresponding improvements actions, as applicable.
- Advise and validate regulatory strategy for Licensing and external projects. Support due diligence exercises and interactions with partner companies as required.
Education
Degree in biology, pharmacy, medicine, or biochemistry.
Specific expertise
- Pharmaceutical legislation and international registration procedures in the biological products field.
- 5 years prior experience in the pharma industry.
- English (high level) and other languages an advantage.
- Team player with the ability to communicate effectively across several scientific disciplines.
Values
- Care: we listen & empathize, we value diverse perspectives & backgrounds, and we help each other succeed.
- Courage: we challenge the status quo, we take full ownership, and we learn from our successes & failures.
- Innovation: we put the patient and customer at the center, we create novel solutions, and we empower entrepreneurial mindsets.
- Simplicity: we act decisively and avoid over-analysis, we understand why before we act, and we are agile & keep things simple.
