PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Senior Regulatory Affairs Associate
Job Description
• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• To provide regulatory input on procedural and labelling documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:
o Submission delivery strategy
o Review of documents
o Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
• Liaise closely with cross-functional members with aligned product responsibilities.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned labelling deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of Global Regulatory Operations and Marketing Companies.
• Expertise in core labeling documents including the Company Core Data Sheet (CCDS), and Core Patient Information Leaflet, including labelling history documents.
• To perform CCDS review and submissions to health Agencies
• To prepare, review and submit safety variations to Health Authorities and also perform post Approval labelling related updates (where applicable)
• Expertise in SmPC, SPL, USPI, PM, Artwork.
• To ensure that appropriate, up-to-date records are maintained for compliance, including maintaining repositories of current regional labeling and ensuring proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents.
Candidate Profile
Masters in Pharmacy
6-8 years of relevant experience. Willing to work in EU shift.
Additional Information
Job ID : 55579BR
Experience : 6-8 years
Qualification : M.Pharm
Location : Bengaluru, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 20th November, 2019
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