Associate Director - Regulatory Affairs
Reference:
Job Type: Permanent
Location: Belgium, United Kingdom,
Salary: Competive
Start Date: Feb 2012
Job requirements
- Responsible for the development and implementation of the CMC regulatory strategy for all aspects of a product /groups of products and ensuring the strategy is designed to deliver a timely approval taking into account the needs of the business and the patients.
- Responsible for Medical Device regulatory submissions as related to combination products
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Independently write high-quality CMC regulatory documentation for submission, respecting agreed CMC global regulatory strategies, assuring technical congruency and balancing business needs with regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- Responsible for inputting CMC expertise into the global regulatory strategy and global planning, identifying the critical issues and sharing lessons learned.
- Accountable for ensuring the CMC regulatory strategy for the specific product(s) are consistent with the business objectives, have been negotiated (if appropriate) with the regional health authority and that the regulatory risks have been identified.
- As the point of contact for CMC related issues with European Health Authorities, accountable for leading all CMC related interactions, negotiations of product approvals, and quality issue resolution with regional health authorities
- As internal point of contact for device related CMC issues for the ICH regions and responsible for providing RA CMC input to strategy and support for device related submissions as assigned
- Accountable for monitoring changes in the CMC regulatory environment
- Responsible for global CMC submissions from defining content and planning through leading reviews to assure complete and concise submissions to HA.
- To agree adequate regulatory resource and skills to deliver the specific projects
- Be capable of leading significant general projects for the function, including due diligence activities.
- Participate in cross functional teams focusing on continuous improvement and management initiatives.
- Facilitate consistency in regulatory documentation and strategies by critically reviewing CMC documentation and integrating regulatory trends and experiences.
- Facilitate specific training with partners (technical / regulatory groups) - specifically related to devices.
- Represent group in interdepartmental meetings, working groups and initiatives.
- Can assume responsibility for line management and development of direct reports.
Experience
- At least 5-8 years relevant experience in the pharmaceutical industry, with 4 years experience of drug development including product/launch in Regulatory Affairs
- At least 5 years experience with medical device regulatory submissions as related to combination products
- Relevant and significant experience with pharmaceutical device/ combination product submissions in the ICH regions
- Experience elsewhere in the pharmaceutical and medical device industry
- Successful contribution to delivering major competitive regional regulatory approvals supporting optimal launch
- Knowledge of and experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance including devices and combination products
- Direct experience of leading regional regulatory authority meetings
- Sound scientific foundation, to be able to discuss CMC regulatory issues (including devices/combination products) in an authoritative way with technical experts
- Knowledge of manufacturing processes/product development including devices/combination products and preferable experience with biologics.
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