Regulatory Affairs - Senior Manager
SciPro are currently partnered with an innovative, growing biotech company based in the UK. The company are harnessing their world leading science to identify innovative therapies for a specific patient population with a particular focus on oncology.
Due to the expansion of their international development team, they are looking for a Senior Manager of Regulatory Affairs to contribute to the development of the regulatory strategies across their programmes and take the lead on regulatory submissions as the main point of contact for the UK, EU and US health authorities. The role provides an amazing opportunity to join a fast-paced, growing biotech in a leadership position with exposure to interdisciplinary team projects to develop new cancer treatments.
You will be responsible for:
- Defining the regulatory strategies whilst ensuring that product manufacturing and CMC plans are compliant with UK, Europe and USA regulatory requirements.
- Leading on regulatory submissions for IND/IMPD, CTA and MA, acting as the company's regulatory expert.
- Maintaining up-to-date knowledge of regulatory legislation and guidelines and assessing the impact of changes to the company.
- Oversight of vendor selection and reviewing performance to maximise partnerships.
- Writing of regulatory documents
The ideal candidate:
- Will have an advanced degree or equivalent experience
- Experienced in regulatory affairs, including interactions with MHRA/EMA/FDA
- Experienced in regulatory requirements for the development and registration of biological viral drugs/gene therapies/oncology filings.
If you are interested in applying, please send an updated CV to email@example.com