Director, Regulatory Affairs
About the role
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Director Regulatory Affairs
Location: Flexible remote working, based in EU or at one of Global Office locations.
ICON plc, a leading Clinical Research Organisation, our mission is to help our clients to accelerate the development of drugs and devices that save lives and improve the quality of life!
We are looking for passionate, resilient, and inspiring individuals to join our Strategic Regulatory Affairs (SRS) team. SRS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation, CMC and quality assurance. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services
In this role, you will be responsible for regulatory strategy for a combination of current and prospective clients in Europe and Internationally (ex North America) for drugs and biologics. As a senior member of the SRS team, you will further be responsible for the strategic approach and client interactions necessary to securing new and repeat business, facilitating issue resolution and ensuring project/program timelines/budgets are met. You will also maintain client relationships in the support of future business as the position participates in business development activities.
Responsibilities and accountabilities:
Actively anticipate, develop and implement initial or alternative regulatory strategies for contracted clients.
Act as scientific thought leader for ICON. Support initiatives to ensure ICON is at the leading edge of new regulatory developments e.g. DCT, COVID-19, GMO, ATMP development, Cell and Gene therapy etc.
Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise, consulting with other resources within the organisation as required.
Manage workflow including prioritising project objectives, and establishing timeframes for projects with clients and managing client contracts.
Effectively prioritise and complete multiple projects within established timeframes and within budget
Train, coach, and develop assigned individuals to build overall team expertise
Develop and implement strategies and regulatory submissions for PIP, OD, SME, MAA and post-licensing activities as applicable.
Function as primary liaison with regulatory agencies for designated projects and designated clients
Conceptualize and draft complete proposals based on a client idea or (Request for Proposal (RFP) including Independent development of project plans and scientific content for clients. Achieve a good conversion rate of submitted to won proposals.
Act as scientific thought partner with the client and the project team throughout the project.
Initiate and nurture client relationships and maintain contacts to build reputation.
Speak at conferences and webinars, as appropriate.
May lead a team
Knowledge/Skills/Attributes
Thorough working knowledge of local and global Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines
Effective project management skills
Ability to make decisions independently and operate autonomously
Sound listening, conflict management, and negotiating skills
Excellent planning, organisation, interpersonal, time, and change management skills
Demonstrable good problem solving, judgement, and decision-making skills
Ability to develop and maintain excellent rapport with clients
Knowledge of business development process
Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding
Planning and organisation: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively.
Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation
Experience in client interaction and/or in a consulting environment is advantageous
Education/Experience:
Bachelor's degree in a relevant discipline, preferably in life sciences, or other healthcare field.
Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field may be beneficial.
Minimum of 12-15 years related experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on EU and International (Ex North America) Regulatory Affairs
Experience supporting client development activities and people management.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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