Regulatory Intelligence Manager FSP
Share
Job Location:
Philadelphia, PA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
ROLE: Regulatory Intelligence Manager
LOCATION: Fully Remote East Coast is highly preferred
Position Summary
The Regulatory Intelligence Manager will play a pivotal role in monitoring analyzing and communicating global regulatory developments that impact the clients pipeline and operations. This individual will serve as a strategic partner to cross-functional teams ensuring timely dissemination of insights and proactive regulatory strategy alignment.
Key Responsibilities
- 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: Liaise with relevant internal stakeholders and evaluate the implications of regulatory updates on the clients development programs and operational practices.
- 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 internal newsletters alerts and briefing documents tailored to various audiences. Publish relevant selected content to internal Engage forum.
- Precedent Searches: Contribute to preparatory research and drafting of responses to precedent searches requests from various stakeholders.
- 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.
Qualifications and Skills
- Bachelors degree in life sciences or related field; advanced degree preferred.
- 5 years of specialized experience in regulatory intelligence within the biopharmaceutical industry.
- Strong understanding of global regulatory frameworks and drug development lifecycle.
- Excellent analytical writing and presentation skills. Perfect command of English.
- Proven ability to translate complex regulatory information 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
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.
Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
