Regulatory Intelligence Senior Manager
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Job Location:
Morrisville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
OfficeJob Description
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.
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.
Qualifications and Skills
- Bachelors degree in life sciences or related field; advanced degree preferred.
- 10 years of specialized experience in regulatory intelligence in US EU and global (in the order of preference) 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
- Available for approximately 20% travel
- Business-level English proficiency required additional languages beneficial
Thermo Fisher values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)
Required Experience:
Senior 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
