Manager of Regulatory Affairs

Conteúdo do emprego

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

• Formulate/organise/file/manage all regulatory applications and submissions (CTAs, ODDs, MAAs, amendments, variations and others) as required in the European region. Guaranteeing that submissions are completed and are of a high-quality standard.
• 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 the preparation and conduct of Health Authority meetings, as necessary to support regulatory filings and applications, including the preparation and coordination of briefing packages.
• 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.
  

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Anthony Hughes on +44 203 831 7670.

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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