• Great location in Northern Madrid, Spain
• Paying up to €75,000 for the perfect candidate
• Innovative Biotechnology organisation, aiming to treat life-threatening disorders with Biosimilar treatments
• Role is working with other senior Regulatory professionals to devise and implement global regulatory strategies for Biological products
This role will see the successful incumbent be responsible for the implementation of regulatory strategies, the coordination and preparation of submissions to register Biological products into International markets, including Europe, Latam, MENA and the Asia-pac region. Essentially, you will ensure the timely registration of products in compliance with all of the regulations and guidelines that are applicable to my client’s products.
My client is a biopharmaceutical company that specialises in the research, development and manufacturing of Biosimilars for the treatment and prevention of complex diseases in a variety of niche therapeutic areas.
Whilst initially a European company, still maintaining their global HQ in Europe, my client has a worldwide presence in all major pharmaceutical markets, with full-line research and manufacturing capabilities as well as a team of expert professionals located across the globe.
• Define strategies for regulatory submissions to obtain and maintain approvals for products in International markets. These markets include Europe, Asia, Middle East, North Africa, North America, CIS.
• Together with other technical departments, Participate in the preparation and review of documents such as study protocols, Pre-Clinical and Clinical study reports, regulatory documentation, SmPC, PI, labels.
• Manage the changes of dossiers to make them suitable for International markets. Organise the submission and registrations process and supervise the partner RA teams for the submissions of documentation.
• Contact with the applicable local Health Authorities
• Organize and Represent the company at meetings with National Competent Authorities.
• Coordination of responses to deficiency letters according to the prescribed timelines
• Work with the Clinical teams to submit Clinical Trial Applications and support that Clinical team in Health Authorities meetings.
• Participate in Regulatory Audits and work together with other departments to correct any potential non-conformances
• Once the products are on the market, maintain the regulatory Life cycle of the product
• Provide regulatory support in the product launch and liaise with the supply chain and marketing teams
• Carry out Scientific Advice meetings with regulatory agencies
• 6-10 years’ experience within a Regulatory position, ideally working on a strategic as well as operational level
• Minimum of 2 years’ recent experience working within a Bitoech/Biosimilars organisation or business unit
• Deep knowledge of European regulations for Biotech products is essential, particularly centralised procedure. Knowledge of LATAM, APAC and MENA regulations a bonus
• Fluent English, Spanish language skills not essential
• Must be willing to travel internationally as the role requires
• Good commercial acumen to effectively communicate with other areas of the business and act with the good of the company in mind
This is a permanent role
For further information or to apply for this role please contact Chris Gibson on 01403 216216 or email your CV to firstname.lastname@example.org