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Senior Regulatory Affairs Consultant

Location: High Wycombe, Buckinghamshire Salary: £55.00 - £68.00 per hour
Sector: Pharmaceuticals Type: Contract
Contact: Matt Henocq Job Published: 12 days ago

Regulatory Affairs Consultant (Oncology)

Main Responsibilities:
Strategic and tactical input in development, post-approval and Life cycle management
* Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates
* Drive understanding of central and national regulatory requirements
* Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
* Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
* Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labeling
* Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan


Liaison with Regulatory Agencies and Local Operating Companies
* Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments
* Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate
* Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings
* Determine timing and strategy for Regulatory Agency meetings and scientific advice
* Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies. Define attendance in consultation with GRL and CDT. Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies
* Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed
* Negotiate labeling with Regulatory Agencies, going through each of the back-up strategies if necessary


Input in document and process development
* Advise team on required documents and processes to support Regulatory Agency contacts and submission
* Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents
* Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements as appropriate
* Define, generate and submit appropriate data-driven (regional/local) responses to Regulatory

Agency questions
* Ensure necessary regulatory activities are planned and adequately tracked in company systems
Clinical Trial Applications (CTA)
* Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling
* Advise team on required documents and submission strategies in preparation of CTA
* Ensure CTA submission packages are complete and available according to agreed timelines


Marketing Authorization Application (MAA)
* Provide regulatory support throughout registration process
* Provide regulatory support throughout life-cycle management
* Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)
* Ensure timely MAA availability, track critical path activities
* Responsible for submission and acceptance of MAA
* Ensure country-specific submission packages are made available to the LOCs


Resource Planning and Management
* Determine resource requirements for assigned projects and anticipate needs for major filings
* Provide line management, coaching and guidance to Regulatory Professionals as appropriate


Job Requirements
Education and experience
* University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
* Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
* Experience with EU regulatory procedures (CP, MRP, national)
* Experience in working in project teams and/or a matrix organization
* Previous Oncology experience required

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. Privacy Policy. Equal Opportunity and Diversity Policy.

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