Our client is a Spanish-based global healthcare corporation, involved into different fields of the chemical and pharmaceutical industry, comprising the entire drug development process chain, and specialized in the research, development and manufacturing of active ingredients and drugs, for both human and veterinary use. Comprehensive presence worldwide in more than 30 countries (Europe, United States, Latin America and Asia) includes 8 commercial offices, 8 industrial facilities, 8 R+D centres and more than 5,000 professionals globally deployed.
- Global Registration products.
- Develop & maintain regulatory knowledge of target regulations.
- Liaising with Regulatory authorities and partners.
- Generation and compilation of data in accordance with global requirements, included worldwide.
- Preparation of product registration dossiers.
- Evaluate and prepare regulatory submissions.
- Other ad hoc duties as required.
Main tasks and responsibilities:
- Prepares and/or supervises the planning and preparation of high quality International Technical Documentations and advises on the development of regulatory documents including reviews and liaison with speciality departments (e.g. Central Strategic Marketing, Strategic Product and Portfolio Management) and external partners.
- Works with product development teams and international regulatory divisions to advise on global regulatory requirements and to ensure international compliance of technical documentation. Liaises with external partners and/or other colleagues/departments to manage regulatory queries within firm timelines.
- Conducts and/or supervises regulatory procedures for conformity assessments, initial marketing authorizations, notifications and registrations worldwide. Obtains Free Sales Certificates to support global marketing authorizations in liaison with affiliates and external partners.
- Partners with international regulatory colleagues. Collaborates and aligns with regulatory functions in Madrid HQ as well as other locations. Regular follow up progress on regulatory submissions with country offices and/or partners in co-operation with our Client’s Business Units including tracking.
- Represents our Client at Meetings with Notified Bodies and National Competent Authorities.
- Manages contractor selection, contracting and co-ordination of contracted activities for assigned projects.
- Contributes to relevant parts of the project goals and is responsible for meeting project milestones.
- Develops detailed understanding of and ensures compliance with all pertinent statutes, regulatory standards, GxPs, ISO norms, guidelines and technical requirements in target markets.
- Must hold at least a Bachelor’s degree in Life Sciences or related subject.
- 6/8 years + Regulatory experience (desirable experience also in Latin America, Europe and Asia).
- Some experience of export registration issues.
- Biologics experience.
- Customer oriented.
- Knowledge of CMC, MAA is desirable.
- Willing to travel, at least 25%
- High level of English & Spanish preferable.
- Good interaction and team working capacity.
- Experience in coordinating people.
If you are interested, please contact us (Reference: BIOTECH INTERNATIONAL REGULATORY AFFAIRS MANAGER – SPAIN) and we will come back to you as soon as possible.