Manager of Regulatory Affairs
vor 10 Stunden
Proclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion.
Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of multiple, first-ever disease treatments at speeds faster than the industry average.
As a result of their partnership with Regeneron Pharmaceuticals to clinically develop, commercialise and distribute Evkeeza® (Evinacumab) across Europe, we are seeking a Manager of Regulatory Affairs who will play a pivotal role in driving this launch. This role is on a permanent basis located in Basel, with flexibility to work from home.
**Responsibilities**:
- Assist with the planning of responses to questions from Regulatory Authorities.
- Progress and/or offer critical evaluation of papers (e.g. protocols, reports, responses to Health Authority questions, SOPs) correlated to clinical, nonclinical or manufacturing, as needed.
- Produce and retain regulatory submission timelines and trailing deliverables to confirm ambitions are met.
- Interface with functional areas (CMC, Nonclinical, Clinical, Commercial) to identify and obtain information required for regulatory submissions.
- Contribute to the development of regulatory strategies, particularly for region Europe.
- Proactively identify project issues and propose appropriate regulatory strategies to mitigate risks.
- Deliver regulatory support related to the maintenance of commercial products in Europe including updates to labelling and packaging and assisting with the review of promotional/disease awareness and internal training materials.
- Provide support maintenance of product information and other documentation in national databases.
- Partake in Regulatory Affairs sub-team meetings providing input on development strategy and submission timelines to support EU regulatory goals.
- Interface with global regulatory authorities and consultants as needed.
Support in creating and maintaining an EU reporting dashboard for teams and management.
- Contributes or leads smaller regulatory projects including EU regulatory research as needed.
- Participate as required to the development of SOPs to support regional and local processes.
- Organise with external service providers and keep regulatory spending overview up-to date.
- Uphold knowledge of current European regulations and guidances governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area.
**Skills & Requirements**:
- A BS/MS in a science area required; a PhD degree preferred; attaining a Regulatory Science program is preferred.
- Solid scientific background with at least three years of experience in Regulatory Affairs in the biotechnology or pharmaceutical corporation.
- Knowledge with product development within a project management role with applicability to early phase non-clinical, clinical or CMC drug development.
- Successfully manage major submissions and critical projects to deadlines.
- Detailed understanding of global drug/biologics regulation, particularly in Europe.
- Outstanding attention to detail with solid coordinating, task planning and time management skills.
- Great verbal, written and interpersonal communication skills.
- Can work self-sufficiently and in a team environment, with strong leadership, negotiation and influencing ability.
- Tactical thinker and problem-solver capable of providing advice, identifying risks, decision making and implementing plans and risk mitigation strategies.
- Robust comprehension of European drug development regulations and guidelines; Knowledge of foreign regulations and ICH is advantageous.
- Knowledge of orphan drug development is desirable but not essential.
- Knowledge of biologics requirements is a bonus but not crucial.
- Applied knowledge of association and productivity tools, i.e. Office365, EDMS, virtual collaboration tools are expected.
- Outstanding attention to detail with solid coordinating, task planning and time management skills.
- Great verbal, written and interpersonal communication skills.
- Can work self-sufficiently and in a team environment, with strong leadership, negotiation and influencing ability.
- Tactical thinker and problem-solver capable of providing advice, identifying risks, decision making and implementing plans and risk mitigation strategies.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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