This is a Fixed Term Contract for 6 months. This is what you will do: The Regulatory Affairs Senior Specialist willCoordinate and prepare submissions to regulatory authorities such as CTA/IND submission and amendments in support of ongoing development programs, under the supervision of the regulatory leadProvide Regulatory input for applications submitted for Alexion products after discussion with regulatory lead if appropriateSupport regulatory lead as regulatory representative in the respective teams charged with preparing submissions and communications with Health Authority regulations and company policies. Participate in the development of processes and procedures relevant to the submissions. Support for communications to responsible Regulatory Agency personnel regarding submissions after discussion with regulatory lead if appropriate.You will be responsible for: Prepare regulatory submissions and contacts with regulatory agenciesParticipate in the development of processes and procedures relevant to the submissions Works collaboratively with the product team to ensure that quality and regulatory standards are considered throughout the product development life cycle.Share information on regulatory requirements.Continually monitors the regulatory environment to maintain expertise in regulatory principles, new issues, competitive products, and implications.Performs regulatory intelligenceSupports the regulatory lead as regulatory representative within crossfunctional teams to provide expert interpretation of relevant laws, regulations, and company policies.Propose improvement of the submissions processAbility to understand and interpret regulatory requirements and translate this into concrete propositions You will need to have: 2 years experience in Regulatory Affairs within the pharmaceutical industry is required; biotech is a plusWorking knowledge of Agency regulations and industry standards pertaining to regulatory is essentialKnowledge of Clinical Trial ApplicationsKnowledge of the drug development process is highly preferredInitial experience on regulatory submissionsGood communication experience with regulatory agenciesUnderstand context and content of regulatory submissionsGood English oral and written communication skills are requiredUnderstanding of requirements for regulatory submissionsAbility to support projects to completion/experience working in project teams Ability to work in a flexible environment to meet all regulatory requirements and business requirementsGood organizational skillsThe duties of this role are generally conducted in an office environment.
As is typical of an officebased role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: Experience with the EU Clinical Trial Regulation and related submissions is a plus #LIMH2#LIHybrid
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