Regulatory Affairs Senior Manager (remote-based)
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Hobson Prior currently have an exciting remote-based position for a Regulatory Affairs Senior Manager to join an established team of experienced colleagues, where the main focus in the role is to ensure documentation for products under development of drugs in accordance with current regulatory requirements. This is a remote-based position and will be initially on a 6-month contract with the possibility of an extension.
- Accountable for coordinating and submitting applications to the authorities.
- Be an expert on processes, applications and regulatory environment to build the regulatory strategy together with the expert teams.
- Provide generalist comments on the content of regulatory applications.
- Be a regulatory representative in the Projects/Products Teams.
- Cooperate with authorities, partners, regulatory consultants and other departments.
- Develop and update regulatory SOPs and participate in operational excellence work, if applicable.
- Provide regulatory input to project and product forecasts Full time and daytime.
- A strong team-player with collaborative, respectful and flexible attitude and high engagement.
- Able to collaborate with different parties both external and internal.
- Able to and enjoys working in a volatile environment.
- Highly self-motivated and able to drive activities.
- Have excellent communication skills.
- Have a university degree in Life Sciences.
- Have at least 5 years' experience from pharmaceutical industry or competent authority (registration, development, maintenance).
- Have regulatory affairs knowledge.
- Fluent in English.
- Previous experience working with clinical development is admirable.
- Experience of working with biotechnological products is admirable
- Experience in immunology is admirable.
- Experience of regulatory requirements in markets outside EU and US is admirable.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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