Senior Regulatory Affairs - High Point, United States - Thermo Fisher Scientific

Description

Job Description

When you join us at Thermo Fisher Scientific, you'll be part of a hard-working and driven team that shares your passion for exploration and discovery. With revenues of approximately $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world. Ranked #69 on the 2023 Fortune 500 list, you'll discover endless opportunities to grow a rewarding career as part of the world leader in serving science.

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

Position Overview

The role is responsible for leading site regulatory activities related to the development and commercial products at the High Point, NC site. This role involves writing and reviewing CMC documents in compliance with pharmaceutical regulatory requirements, including US FDA 21 CFR, ICH guidelines, and GMP and publishing and submitting these in eCTD format to the FDA. Additionally, this position requires representation and advisory support to the Regulatory Affairs (RA) team in R&D project teams, providing expertise on registration files, facilitating regulatory problem-solving with clients, interacting with the FDA as the US agent, and supporting the setup of bioequivalence studies.

What will you do?

Key Responsibilities

• Collect, write, and maintain documents for regulatory submissions and product surveillance
• Regulatory submission strategy
• Regulatory support and answering of regulatory questions
• Act as a US agent for the Softgel BU
• Assessment of RA changes and change controls
• Represent Regulatory Affairs in project teams
• Pharmacovigilance support
• Biostudies

Additional Responsibilities:

Competencies:

• Interaction and Influence: Effective collaboration with colleagues internally and externally regarding documents, projects, and implementation of new guidelines. Act as a subject matter expert (SME) in project teams. Able to give significance to project information and/or implementation of the new guidelines; development and deepening of knowledge in special field of interest and interpretation of consequences for his own organization
• Knowledge Management: Ability to take on new information, implement new systems and work instructions, and share knowledge effectively within the organization. Make decisions related to site regulatory activities.
• Expertise/Knowledge: Deep understanding of regulatory requirements, evaluation and resolution of regulatory and technical challenges. Work independently, take initiative, and make decisions within guidelines.
• Results-Orientation: Direct oneself and/or others towards goals, meet agreed timelines, and develop a clear vision for achieving goals.
• Analytical Capacity: Distinguish essentials from side issues, penetrate to the core of problems, and predict possible consequences of envisaged steps.
• Flexibility: Adaptability to changing priorities, ability to switch tasks, and manage multiple projects simultaneously.
• Planning Skills: Excellent planner, able to envision short-term milestones vital to achieve regulatory goals, prioritize and manage workload to meet timelines.

Knowledge and Experience:

• Bachelor's or Master's degree in Science or Pharmacy.
• Minimum of 7 years relevant regulatory experience in the pharmaceutical industry.
• Strong knowledge of regulatory dossier content, full applications, and CMC sections (writing and reviewing according to US FDA 21 CFR and ICH guidelines).
• Strong knowledge of generic drug regulations and ANDA requirements.
• Strong with pharmaceutical guidelines, eCTD software and submissions, GMP, USDA, EU and other regulatory requirements, US/NF pharmacopeia, EP monographs, and pharmacovigilance guidelines.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Proficient in English (speaking and writing).
• Excellent writing, communication, planning, organizational, and time management skills.

Note: This job description is based on the provided information and may not cover all aspects of the role.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement. We offer competitive compensation, annual incentive plan bonus, healthcare, 401k match, and a range of employee benefits To learn more about our total rewards package visit .

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Benefits & Total Rewards | Thermo Fisher Scientific

We strive to bring together and develop extraordinary colleagues who share our passion for making significant contributions to the world.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.