Regulatory Scientist
The Regulatory Scientist, is responsible for all regulatory strategic and operational tasks for a range of investigational and licensed products.
Proposes or contributes to regulatory strategies, contributes to their execution and closely cooperates with other regulatory functions and, as applicable, regional and local regulatory managers regarding new license applications for development products and for relevant change applications with a view to obtain HA approval in the fastest and most efficient way while ensuring compliance with the regulatory requirements pertaining to product approval and license maintenance.
Serve as Regulatory Scientist, for one or more programs/projects.
•Propose regulatory strategies considering regulatory requirements, classification of changes, scheduling and priority setting.
•Under supervision of the Team Lead / TA Lead ensure all regulatory activities are in alignment with the strategic direction of the GRAST.
•Contribute to a GRA Strategy Document for complex projects and provide review of regional regulatory strategies.
•Monitor timelines
•Participate in GRASTs, as applicable.
Contribute to a submission schedule for each product, reflecting all scheduled submissions, e.g. new license applications, commitments, variations, renewals, clinical trials, pediatric plans, orphan drug designations, product identifiers / names, periodic safety reports etc.
Contribute to the compilation of relevant high quality documentation for submissions, including applications for new licenses, variations, license renewals, responses to questions, clinical trials, pediatric plans, orphan drug designations, product identifiers/names, DSURs and changes according to agreed schedules while taking into account regional specific requirements. This comprises also related responses to questions of the submissions.
•Ensure that dossiers meet the content and format requirements for relevant regulatory authorities via effective communication with the Team Lead/TA Lead, Regional Regulatory Affairs Manager/Local Regulatory Affairs Manager (RRM/LRM), GRLs and other GRAST members.
Creates check-lists of required documentation, ensures the timely submission readiness of documents and tracks availability of all required documents.
Performs or contributes to regulatory procedures like new license applications, renewal applications, change applications, period safety reporting submissions, submissions of other documents required to fulfill regulatory post approval commitments and international Scientific Advice meetings.
•In a timely manner, place the relevant regulatory documentation at the disposal of other GRA Functions, the Regional Regulatory Affairs Manager/Local Regulatory Affairs Manager (RRM/LRM) or submit to the Health Authorities, as applicable.
•Communicate submission dates and approval dates to stakeholders, as applicable.
•Coordinate the development of responses to HAs for the respective GRA Function, as applicable.
•Support Global Regulatory Strategy Team (GRAST) members for the strategy, planning and preparation of regulatory documents
Coordinate and participate at Scientific Advice Meetings under supervision of EU Regulatory Affairs Franchise/TA Lead.
Requirements:
Education and Qualifications:
A degree in Life science (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
•Regulatory experience in a biotech or plasma protein company is an advantage.
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•Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product.
•Understanding of the principles of GMP, GCP and GLP.
•Strategic and tactical thinking ability, complemented by a hands on operational approach and business planning orientation.
•Ability to identify the ?big picture and opportunities/major issues and link day to day tasks with long term goals.
•Demonstrated ability to deal with rapid change.
•Demonstrated sound judgment and flexible approach to managing situations.
•Customer service focus.
Worker Type:
Employee
Worker Sub Type:
Regular
