BE - Specialist 4, Regulatory Affairs

EMEA Regulatory Liaison (Regulatory Affairs)
1. Strategic and tactical input into development, post-approval and life cycle management
? Participates in the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) if requested.
? Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional climates;
? Leads and facilitates cross functional activities related to regional strategy.
? Drive understanding of central and national regulatory requirements;
? Develop a deep understanding and ensure effective implementation 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;
? 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;
? 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
? 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)
? Leads and oversees the preparation of dossier content according to the strategic plan for the region and health authority commitments.
? 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

5. General
? Responsible for the critical review of submission documents to ensure compliance with regulatory requirements;
? Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints;
? Serve as the Regulatory representative on specific multi-discipline teams;
? Keep abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidances and requirements related to those areas.

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.


Principle responsibilities for EMEA Regulatory Liaison include:
? Regulatory Strategy
? HA Interactions & Op Cos
? EMEA regional regulatory agencies as appropriate.
? Submissions
? Labelling
? Regulatory Input into Other Functions
? People Relationships


KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:
Knowledge:
? Knowledge of the regulatory environment, guidelines and practice of EMEA regions;
? An understanding of competitors in the area and what they did/are doing in early and late development in assigned therapeutic areas and knowledge of labeling aspects;
? Understanding the impact of a new law, guidance or ruling on drug development.

Education and Experience:
? University degree ? medical paramedical (pharmacy, biology, veterinary etc) or equivalent by experience;
? Experience in regulatory affairs;
? Teamwork experience.

Communication and Skills:
? Project Management skills;
? Oral & written communication skills;
? Organization & multi-tasking skills;
? Minimum of Bachelors degree in a scientific discipline required
? Advanced degree (MS, PhD, MD or Pharm D) preferred
? Minimum of 8 years of Pharmaceutical experience