Consultant CMC Regulatory Affairs
in Breda, Netherlands.
European Focus – International Coverage
Venn Life Sciences, part of Open Orphan plc, is an Integrated Drug Development Partner offering a unique combination of CMC and pre-clinical drug development expertise, clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients.
“Our vision” is to play a pivotal role in the development of new products enabling disease prevention and treatment. We do this by creating an environment that generates opportunities for employees to stretch their potential and fully exercise their talents thereby consistently providing outstanding service to our clients. We nurture an environment of respect, pro activity, teamwork and above all keep the patient at the heart of what we do.
We are currently looking for a CMC-Regulatory Affairs (RA) Consultant with hands-on experience to join our CMC Team based in Breda, The Netherlands. The successful candidate will have the opportunity to work from home with regular visits to our office in Breda.
Reporting to the Head of CMC, the successful candidate will be responsible for providing input and regulatory guidance on the design, execution and coordination of the CMC elements of client projects, and manage all CMC-RA activities related to the development of (bio)pharmaceutical compounds.
If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.
- Provide scientific input to, write or review the CMC plans, protocols, reports, and documents for regulatory purposes such as IMPD, IND, BLA, CTD, briefing packages for scientific advice meetings, etc; Provide scientific CMC input to the drug development strategy of client projects
- Lead development projects (manage project team, project scope, timelines and budget)
- Contribute to/perform Due Diligence and regulatory GAP analyses of CMC development of candidate drugs and deliver advise how to reach critical CMC-RA development milestones
- Participate in multidisciplinary Drug Development teams
- Engage internal and/or external experts (parties) to manage client’s expectations and to address drug development related matters
- Stay up to date with current trends, knowledge, and developments in CMC-RA and proactively identify opportunities to update and increase knowledge and share with others (internally & externally via training, symposia, articles, etc.)
- Proactively participate in business development to identify business opportunities with current and new clients as well as manage Requests for Proposals to acquire contracts with existing and new clients
- Guide, coach and train professionals in the company
Qualifications & Experience:
- BSc. or higher-level qualification in the field of Life Sciences
- 3-5 years’ experience in early to late stage CMC development activities with a minimum of 1 years’ experience in CMC-Regulatory Affairs.
- Proper understanding of the integrated drug development process (incl. CMC, Non-Clinical, Clinical development)
- Experience in drug substance and/or drug product process development, manufacturing, and/or analytics
- Experience in Project Management
- Experience in Biologics/biotechnological development is preferred
- Ability to find effective solutions to deal with complex matters
- Excellent influencing, organisational and leadership skills with demonstrated ability to listen, lead and motivate particularly across a multicultural organisation
- Ability to multi-task, set priorities, manage workload and meet strict deadlines
- Team worker, who can also work independently, with strong interpersonal skills, ability to communicate effectively and form positive relationships at all levels in and outside the company
- Excellent networking skills to connect to pharmaceutical / biotech companies
- Flexibility to travel and work at different locations
- Excellent command of English
How to apply:
Please forward your CV (in English) by email to Conny van de Linde, firstname.lastname@example.org
PLEASE NOTE THAT DUE TO THE HIGH VOLUME OF APPLICATIONS WHICH WE RECEIVE WE WILL ONLY BE ABLE TO REPLY TO CANDIDATES WHOM WE ARE INVITING FOR INTERVIEW.
We do not require the services of agencies for this role.