AD Reg Affairs - London
NonStop are looking to speak with Regs Professional's, interested to work in London, we currently have an opportunity for an Associate Director of Regulatory Affairs. Currently they are gaining traction in the market as the one to watch allowing you to gain huge exposure with a recognised name, giving yourself future opportunities for growth.
- Collaborates to define, develop and lead regional strategies to maximise regulatory approvals and patient access to meaningful medicines in alignment with program objectives. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
- Provides regulatory expertise for assigned project(s) within core therapeutic area of responsibility.
- Mentors team members, if required, to support scope of project work.
- May be called upon to act as deputy to the regional therapeutic area lead and/ or Region regulatory head, attending internal leadership team meetings, as appropriate
- Leads the regulatory working team for own region and represents as needed at project team level
- Ensures regional regulatory lifecycle management strategy and submission planning are written and executed according to plan - or oversees if delegated to vendor.
- Partners with the regional/LOC RA and market access colleagues to understand market access and reimbursement requirements and to ensure consolidated inputs into regional product development plans.
- For the project(s)/product(s) within area of responsibility, collaborates with Global and Regional colleagues for the authoring of regional regulatory strategy and planning.
- Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region (s) of responsibility (E.g. EMA submissions for Europe). Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
The manager is looking for someone with a good working knowledge and experience of EU centralised procedure - both development and post approval - They will be the regional lead for a key oncology product.
Experience with interactions with EMA - Experience of oncology drug development - Experience of EU orphan applications. The client doesn't work on CTAs
Call Daniel Watson at NonStop Consulting now for a confidential conversation. Contact me on D.Watson@nonstopconsulting.com or 0207 940 2105, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a clinical research professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.
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