Regulatory submissions are the most critical milestones in your clinical research program
Over de functie
Yacht Life Sciences has a vacancy for a Senior Regulatory Affairs (RA) Specialist at our client, a global pharmaceutical company.
Your Principle Responsibilities as a Senior RA Specialist:
- Lead and facilitate local operating company (LOC) CMC variation / label change processes from global dispatch to kick-off of local implementation following the Regulatory Management Center (RMC) processes
- Prepare submission plan based on global dispatch and country specifics
- Prepare submission-ready dossier based on local regulations and country specific requirements covered in “recipe book” – in collaboration with LOC staff
- Assess and implement label changes
- Involve specialists for specific process steps, eg. for ePackmat
Required Technical Competencies & Knowledge, Regulatory Strategy & Submissions:
- Good understanding of the pharmaceutical industry and regulatory experience in drug development and/or marketed products.
- Detailed knowledge of local regulations and guidances in the /cluster/region related to full drug life cycle. Understanding of how these apply to specific projects and how to interpret them in the context of the scientific and commercial environment.
- Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products.
- Knowledge of quality and supply chain and potential impact to regulatory procedures and status of products
- Drive execution
- Project management: get things done, drive execution, collaborate in virtual teams, task prioritisation
- Communication skills and cultural sensitivity in working with stakeholders across countries
- Able to communicate in English and have general understanding (incl technical RA English)
- Team player able to effectively collaborate with colleagues in virtual environment and able to do efficient handovers
- Ability to quickly acquire local knowledge and shift between local situations (learning agility)
- Solid RA submission process knowledge; Able to interpret guidances as they apply to submissions in the countries in scope.
- Knowledge of what is needed for dossier components and submissions, how to obtain regional components and understanding of timelines. Understanding of documentation requirements.
- Ability to determine whether documents meet regulatory requirements, and are consistent with the regulatory strategy.
- A minimum of a University degree or equivalent by experience
- 5+ years of submission handling experience
- Experience of working in a virtual team and/or global organization would be an asset .
- Previous experience in RA role as Associate, Professional or similar role is of advantage.
- In depth knowledge of local and regional regulations/legislation.
- Experience in working with limited supervision and able to make independent decisions
- Excellent verbal and written communication skills – proficiency in written and oral English
- Cultural sensitivity and ability to work and thrive in a multi-cultural environment.
- Proactive team player, able to take charge and follow-through.
- Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
- Proficient use of technology including RA tracking systems (TrackWise / SPS/MPD) - preferred
This will be a secondment position via Yacht, a minimum availability of 32 hours per week is essential. This role can also be performed by a freelancer (ZZP). We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
The Regulatory Management Center is a new regional organization to handle the majority of LOC activities led by senior regional regulatory staff, where they will handle tactical LCM processes (CMC Variations and Labeling Changes) in the region. The Center will be embedded in the AP, EMEA and LA regional organizations, and it will work in close collaboration with the respective LOCs and regional and global departments.
The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports) and LOC team members (matrix organization). The responsibility of RMC Professionals is to lead wide range submission processes for multiple countries, preparing country-specific submission ready dossiers,manage Agency questions when required and ensure post-approval activities to take place for those submissions.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.