FSP Regulatory Affairs Manager

Work Schedule

Environmental Conditions

Job Description

Join Us as a Regulatory Affairs Manager – Make an Impact at the Forefront of Innovation
Please read the following job description thoroughly to ensure you are the right fit for this role before applying.
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to provide technical and project leadership over a region(s). As a Regulatory Affairs Manager, you'll offer innovative solutions, including regulatory affairs expertise and client interface, to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Additionally, you will act as a liaison with internal and external clients in the provision and marketing of these services.

As a Regulatory Intelligence Manager will play a pivotal role in monitoring, analyzing, and communicating global regulatory developments that impact client’s pipeline and operations. This individual will serve as a strategic partner to cross-functional teams, proactively identifying relevant developments and translating them into actionable insights to inform regulatory strategy and operational planning.
What You’ll Do:

• Monitor & Analyze: Track global regulatory changes, guidance documents, and policy trends across key markets (FDA, EMA, PMDA, etc.) or stakeholders (EU Commission, ICH, ISO, etc.).
• Impact Assessment: Proactively synthesize information from multiple regulatory sources and, in collaboration with relevant internal stakeholders, assess the implications for client’s development programmes and operational practices. Translate findings into clear, actionable insights and recommendations for client’s teams.
• Stakeholder Alignment: Interact with Regulatory Affairs, Clinical, Quality, Pharmacovigilance and Legal teams to ensure alignment and awareness with key areas of interest and hot topics.
• Communication: Contribute to the creation of and distribute client’s newsletters, alerts, and briefing documents tailored to various audiences. Publish relevant selected content to client’s Engage forum.
• Precedent Searches: Conduct targeted regulatory precedent searches and synthesize findings into clear responses that inform stakeholder decisions.
• Knowledge Management: Maintain a centralized repository of regulatory intelligence resources and ensure accessibility across teams.
• External Engagement: Participate in industry forums, working groups, and regulatory intelligence networks to stay ahead of emerging trends.

• Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects ofmoderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensures quality performance for key/managed projects.
• Manages project budgeting/forecasting functions.
• Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
• Provides matrix/project leadership, training and guidance to junior team members.
• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
• Participates in launch meetings, review meetings and project team meetings
Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Excellent English language (written and oral) communication skills as well as local language where applicable

• Strong understanding of global re