- As part of multi-functional team, the Regulatory Affairs Manager will be responsible for the operational and logistic aspects for his/her assigned projects and he/she is the primary point of contact for any regulatory related issue, both internally and with external stakeholders.
- The function is also responsible for adhering to regular planning of tasks in accordance with program timelines, performing the required activities to keep the assigned project(s) on track.
- It is a key function to coordinate Health Authorities’ interaction and compilation and maintenance of regulatory documentation in collaboration with designated Subject Matter Experts (SME). Therefore, it is expected that the Regulatory Affairs Manager should be able to work independently as well as feel comfortable in coordinating a multifunctional team.
Most important task of the job:
- Propose, in collaboration with the Project Team, timing and scope of regulatory interactions for further evaluation by higher management
- Manage, in line with company’s procedures and in collaboration with the project team, the preparation, compilation (including writing as necessary), assembly, review and filling (as appropriate) of regulatory documents in relationship with the drug development process
- Manage, in line with company’s procedures and in collaboration with the project team, the timely response to Health Authorities queries
- Participates in change control management according to company's change control procedures
- Preparation and maintenance of a central source of Regulatory Intelligence information, including but not limited to his/her assigned project and general EU and US regulatory guidance information
- Ensure all program deliverables are met according to timelines, budget, operational procedures and quality standards
- Maintenance and archiving of regulatory documentation according to internal Standard Operating Procedures (SOPs)
It is expected that the Regulatory Affairs Manager will have to travel internationally.
The Regulatory Affairs Manager will report to and will be supervised by the Vice President Regulatory Affairs.
Qualification and Experience:
Education: University Degree in Pharmacy, Chemistry, Biology, Biotechnology or equivalent, PhD preferred.
Languages: Fluent in English, both written and verbal. Any additional language is advantageous.
Very good knowledge and understanding of FDA/EMA and ICH guidelines and regulations is required for this role, as well as very good understanding of Operational aspects associated with dossier submissions in ICH regions.
- 5+ years of experience in the EU and/or US. Working experience with Regulatory Affairs for biologic, ideally monoclonal antibodies.
- For this role, a broad experience in all phases of drug development as well as a strong operational background with regards to regulatory submissions in US and EU as well as Health Authorities’ interaction is required.
- Prior experience with the development of biological/bio similar drugs is desirable.
- A proven track record of effective project management is required as well as high level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills are expected.
- This role requires excellent communication, combined with team work, prioritization and collaboration skills.
- You are an open minded person with regulatory affairs capabilities, who wants to be part of a highly diversified and challenging development environment .
To be part of a growing team dedicated to improving access-to-medicine, we offer opportunities to bring forward ideas, lead change and ongoing opportunities for personal development and growth in an international company.