Senior Regulatory Affairs

### The Quality Difference at Thermo Fisher Scientific

What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

### Work Schedule

Other

### Environmental Conditions

Office

### 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.

Join us as a Regulatory site lead and get the opportunity to develop yourself as a regulatory professional through exposure to exciting challenges in an evolving environment while interacting with multiple functions.

### How will you make an impact?

Patheon Softgel Inc. in High Point, North Caralina, is part of Thermo Fisher Scientific – Pharmaceutical group focusing on contract manufacturing activities (CMO) and development of mainly generics OTC products. The regulatory manager will lead site regulatory activities related.

This position requires registration expertise (full ANDA) including writing and reviewing of pre- and post-approval applications, handling of product life cycle management, e-publishing and submission to the FDA.

In this role you will also contribute to the business growth by defining regulatory strategies to the latest standards, advising internal partners on regulatory requirements, facilitating regulatory problem solving with customers, acting as the site US FDA agent and supporting setup of bioequivalence studies.

Furthermore, you will strengthen regulatory knowledge and monitor and implement new regulatory requirements impacting the business unit.

And finally, you will be instrumental in ensuring regulatory compliance.

### What will you do?

#### Regulatory services

– Advise project team on regulatory matters, define strategies per latest requirements
– Delineate options for regulatory submissions, approval pathways and compliance activities and advocate for the most suitable regulatory approach
– Deliver ad hoc expertise on registration files relevant to clinical and commercial applications (ANDAs and Post Approval Changes), assess overall regulatory acceptance/ risk, generate registration files deliverables (CTD module 1 to Module 5 and supportive documentation, including answering Deficiency Letters) as per agreed timelines with a “Right the First Time” mindset to ensure a smooth file acceptability
– Proceed with the e-publishing and submission to the authorities
– Communicate and interact with the FDA as the Softgel BU US agent
– Facilitate regulatory problem solving with customers
– Be accountable for yearly regulatory revenue target achievement
– Support set up of bioequivalence studies, allocating the Reference Listed Drug to be used in the study

#### Regulatory Surveillance

– Monitor regulatory requirement developments and provide interpretation and mentorship to team members for implementation
– Provide SME consultation to the organization and ensure increased site regulatory knowledge

#### Regulatory Compliance

– Handle all aspects of products Life Cycle Management (from the change control assessment, regulatory requirements definition, crafting of supportive statements and regulatory submissions, to translation into master documents)
– Be the point of contact for any regulatory requirements interpretation
– Support pharmacovigilance activities (Adverse Drug Reports sharing) in a timely manner in compliance with relevant regulation
– Deputize the Softgel RA Sr Manager in strategic meetings (R&D and or improvement meetings, with customers) and for key document signatures
– Set up and/ or maintain regulatory compliance systems (such as but not limited to the product/CMC database)
– Craft and maintain appropriate SOPs, working instructions or job aids

### Education

Bachelor’s degree in a physical or life science, Pharmacy or equivalent

### Experience

Minimum 5-6 years relevant (ANDA) regulatory experience in the pharmaceutical industry
Strong knowledge of regulatory dossier content, full applications, and CMC sections US FDA 21 CFR and ICH guidelines)
Familiar with OSD US regulations from development, pre-clinical, commercial to post -approval
Experience with publishing software for eCTD submissions.
Regulatory Affairs Certification (RAC or equivalent) strongly preferred

### Competencies

– Strong knowledge of US regulatory requirements (US FDA 21 CFR) and requirements relating to generics & ANDA, OTC drugs, eCTD publishing and submissions standards, cGMP, USDA, USP/NF and pharmacovigilance guidelines.
– Knowledge of the EU submissions procedure and regulatory guidance, Ph. Eur. monographs
– Ability to evaluate and resolve regulatory and technical challenges
– Very good negotiation and influencing skills
– Appropriate intelligent risk-taking mentality
– Strong interpersonal skills with ability to multi-task and prioritize according to business need
– Excellent writing, communication skills
– Superior organizational, planning and time managements skills
– Proficient in Microsoft Office applications (Word, Excel, and PowerPoint)
– Proficient in English (speaking and writing)

Learn more here