FSP Regulatory Affairs Manager - Regulatory Intelligence MC

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Regulatory Affairs Manager – Make an Impact at the Forefront of Innovation
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 regulatory frameworks and drug development lifecycle.
• 5+ years of specialized experience in regulatory intelligence within the biopharmaceutical industry.
• Experience in CMC or a closely related function is a must.
• Excellent analytical, writing, and presentation skills.

• Excellent written and spoken English, with the ability to communicate complex regulatory information clearly into actionable insights.

• Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities.
• Experience with regulatory intelligence tools and databases (e.g., Clarivate, Citeline, etc.) as well as proficiency with generative AI concepts and use is a must.
• Experience with agentic AI tools and workflows to support regulatory intelligence research, monitoring, and knowledge management, with appropriate human oversight and validation of outputs, is highly desirable.
  • Excellent attention to detail and quality as well as excellent editorial/proofreading skills
  • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
  • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
  • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
  • Excellent negotiation skills
  • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
  • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
  • Superb understanding of medical terminology, statistical concepts, and guidelines
  • Excellent analytical, investigative and problem-solving skills
  • Excellent understanding of budgeting and forecasting
  
  
  Working Conditions and Environment:
  • Work is performed in an office environment with exposure to electrical office equipment.
  • Occasional drives to site locations with occasional travel both domestic and international.