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QA and Regulatory Consultant

Posted on Mar 17, 2020 by Experis AG

Basel, Switzerland
IT
23 Mar 2020
Annual Salary
Contract/Project

QA and Regulatory Consultant

On behalf of our client, one of the biggest medical devices company based in Allschwil we are looking for a QA and Regulatory Consultant.

This is a contracting position, starting in April until the end of July 2020 with extension possibilities.

Primary Tasks and responsibilities

1. Strategic and tactical input in development, post-approval and Life cycle management

Advise the Project/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

2. 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

3. 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

4. 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

5. 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

Your skills/experiences are:

  • University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
  • Breadth of regulatory experience in drug development and commercialization (eg 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
  • Negotiating and conflict handling skills
  • People management skills
  • Project management skills
  • Oral & written communication skills in English
  • Organization & multi-tasking skills
  • Knowledge of the applicable therapeutic area
  • In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions

Start: 01/04/2020

End: 30/07/2020

Location: Allschwil

Workload: 100%

If you are a result-oriented QA/RA consultant currently looking for a challenging new position that applies to your skills, then we look forward to receiving your application!

Reference: 864533837

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