Associate Director Regulatory Affairs



Associate Director, Regulatory Affairs Europe, will oversee EU regulatory activities for all assigned products and provide guidance, direction and support on regulatory and submission strategy and planning to relevant project teams, working closely with Regulatory Project Leads and other project team members in Japan and the US.

Main responsibilities:
• Actively participates in project team meetings; by applying regulatory expertise and knowledge of regional regulatory requirements; provides strategic input, regulatory support and guidance
• Supports and leads where requested to the preparation of key regulatory documents (e.g. MAAs, CHMP Scientific Advice, PIPs), working closely with cross functional colleagues and
external consultants as required
• Supports and leads where requested to the interactions with European regulatory agencies (e.g. EMA, MHRA)
• Supports post-marketing licensing requirements and ensures effective liaison across the organisation to optimise regulatory strategies
• Manages CTA strategies and the CTA submission process, ensuring successful approval of CTA applications, including appropriate oversight and management of CRO vendors
• Leads preparation of responses to questions from Health Authorities (MAA, CTA)
• Assumes ownership and responsibility for regulatory projects, working collaboratively with stakeholders internally and externally
• Supports the preparation for and conduct of Health Authority inspections and independent audits
• Liaises with internal functional groups in London, US and Japan and corporate partners related to clinical and post-marketing submission activities to obtain and/or provide information/data for regulatory submissions
• Mentors, instructs and provides guidance to internal and external parties, including consultants and CRO’s and plans, assigns and directs work, managing competing priorities as appropriate
• Mentors assigned team members and provides line management as required
• Ensures thorough technical review of regulatory documents for approval prior to submission to health authorities
• Contributes to the development and maintenance of SOPs to reflect best practices and supports the continual development of optimal processes for the regulatory function of the company
• Fosters a strong understanding of the global regulatory view within the company and contribute to this global perspective with European input

Main requirements:
• University degree in life sciences
• Minimum 6-8 years of experience in Regulatory Affairs within the pharmaceutical industry, with specific experience of both development and marketed products
• Experience of post-marketing regulatory affairs, including variations and life cycle management, as well as European procedures (CP, DCP, MRP)
• Experience of working in a cross functional team
• Technically proficient in regulatory affairs knowledge and current with regulations, directives and guidance documents
• Ability to liaise, negotiate and interact with Regulatory Agencies
• Ability to work well within a matrix environment, build team relationships and interface in a global team environment at all levels of management
• Proven ability to plan, effectively coordinate and lead activities simultaneously on multiple projects, all with tight time deadlines
• Good project management skills
• Good interpersonal skills with ability to lead, interact with, focus, and drive consensus
among individuals from a variety of cultures, and disciplines
• Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing at all levels
• Ability to work effectively under pressure

Solliciteer op: Associate Director Regulatory Affairs

CV & Motivatie (max. 3 bestanden: doc, docx, pdf, jpg)
For one of our Pharmaceutical Customer we are looking for an Associate Director Regulatory Affairs with experience in international Clinical Development. They are a growing company, with their European Headquarters newly located in Netherlands. Are you interested in this position? Please apply now!