Regulatory Affairs Specialist

Job title EMEA Regulatory Liaison

Level: Manager, Associate Director, Director

Department: Global Regulatory Affairs

Reports to: EMEA Regional Therapeutic Area Leader

1. 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

Skills

· Negotiating and conflict handling skills

· People management skills

· Complex project management skills

· Oral & written communication skills

· Organization & multi-tasking skills

Knowledge

· Excellent knowledge of English

· Knowledge of the applicable therapeutic area

· In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions

2. Job Description

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 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

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