Regulatory Affairs Senior Professional - PERM
- Experience Level
- Experienced (non-manager)
Do you have significant experience in the regulatory affairs field? I am looking for a senior professional that is looking to take the next step in their career, working on gene editing, cell and gene therapy and vectors as well as ultra orphan diseases!
I have a role with a leading consultancy to join the team on a permanent basis. This role can be based anywhere in EUROPE.
You will lead multiple MAA's and BLA's at EU level and lead the regulatory strategy in these for your clients.
As a Senior Regulatory Affairs Consultant, you will be responsible for tasks and activities including:
- Providing clients with regulatory consultancy services regarding biologics / clinical development programs through to marketing authorisation and post marketing support.
- Drafting, preparation and review of documentation for regulatory submissions such as (IMPD/IND/MAA/BLA, PIP, ODD), scientific advice briefing documents and applications for orphan designation
- Participation in due diligence activities as part of business development and investment activities by clients
- Contribution to regulatory strategies for client activities.
- Supporting clients as a subject matter expert
- Management and delivery of client projects using internal resources, participating in client and agency meetings. Ensuring assigned client projects meet timeline commitments.
- Client relationship management, including oversight of project plans and timelines, budgets and deliverables
- Company representation at external conferences, including the provision of training workshops
- Business development activities (e.g. identifying opportunities for work, new client meetings etc.)
- Supporting and advising the wider group projects as required.
To be successful in this role you will preferably have an advanced degree (minimum masters) in a relevant life science discipline and must have at least 4-5 years’ experience in a focussed role in the biotech / biopharmaceutical industry or regulatory consultancy industry.
In-depth experience in regulatory affairs and an in depth understanding of regulatory requirements of a range of activities for biological products during development.
Client facing skills.
Excellent English language communication skills (written and spoken) and a strong ability to multitask are prerequisites, as is the ability to present scientific concepts clearly and concisely.
Strong computer literacy.
Ability to work within a global team across multiple location
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