Regulatory Affairs (Clinical)

Company: SRG WOOLF
Location: Durham
Posted on: November 22, 2021

Job Description:

Regulatory Associate JOB DESCRIPTION

• Responsibilities and AccountabilitiesThe role is accountable for:--- the authoring, development and maintenance of the EU SmPC.--- leading cross-functional teams in the development and maintenance of the EU SmPC.--- the generation of responses to European Medicines Agency questions related to prescriber and patient information.--- the role may include authoring, development and maintenance of the Global Product Information (Global/Core datasheet).Expected DeliveryThis role requires prior relevant experience and may include:--- Management of the development and maintenance of the EU Summary of Product Characteristics (EU SmPC) through the early product lifecycle.--- Authoring responses to labelling questions from regulatory agencies.--- Management of the Global PI for marketed products, including presentation of items at Global Labelling Committees.--- Active membership in the Regulatory Matrix Team and submission writing process--- Awareness and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information.--- Supporting Local Operating Companies during implementation of Global PI wording.--- Authoring relevant sections of the periodic safety reports.--- Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling.--- Participation in mandatory training and completion of the training records.Experience, Skills and Specialised Knowledge Required--- ****MUST HAVE direct EU SMPC Labeling experience*****--- Life sciences degree (Pharmacy or healthcare-related degree preferred), PhD or equivalent relevant experience.--- Relevant experience includes regulatory affairs with preference for prior labeling experience.--- Regulatory knowledge with preference for understanding pharmaceutical regulations and guidances related to product information.--- Excellent Scientific Regulatory Writing - the ability to produce written regulatory scientific communications with clarity, accuracy and rigor.--- Data analysis skills -understanding of biostatistics, clinical trial design, and clinical therapeutics SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

Keywords: SRG WOOLF, Durham , Regulatory Affairs (Clinical), Healthcare , Durham, North Carolina