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  • Location

    Leiden, Gemeente Leiden, South Holland

  • Job title:

    Regulatory Affairs Director (a.i)

  • Sector:

  • Job ref:

    46469

  • Start Date:

    2021-07-12

The Company 
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.

Role Description 
As an interim Regulatory Affairs Director you will be responsible for marketing authorisations (50%), CTA and scientific advice (45%) and post-marketing activities (5-10%). 

Responsibilities 
1. 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 labelling
  • - 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

6. 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

Requirements 
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Min 10 years of experience in Regulatory Affairs Manager/Director positions
- 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
- In depth knowledge of the regulatory environment, guidelines and practice of EMEA region


Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 

Contact us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804