AD Reg Affairs - London
- Employer
- NonStop Consulting
- Location
- London
- Salary
- Negotiable
- Closing date
- Jan 16, 2021
View more
- Sector
- Science, Life Sciences, Anatomy/Physiology
- Contract Type
- Contract/Freelance
- Hours
- Full Time
- Organization Type
- Corporate
Job Details
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.
OBJECTIVE:
- 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
ACCOUNTABILITIES:
- 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.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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