Senior Specialist, Regulatory Affairs

Description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week

No relocation is provided for this opportunity

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week

No relocation is provided for this opportunity

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

The Senior Specialist, Regulatory Affairs is expected to understand development of medical devices as applicable to combination products. To ensure, with minimal supervision, regulatory strategies are applied to regulatory submission documents to meet program requirements including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking or those associated with NDAs, BLAs, MAAs. In addition, the Sr. Specialist ensures compliance with West Pharmaceutical Services, Inc.

(West) and government requirements. This position includes supporting internal and external customer regulatory requests.

• Implement regulatory strategies for medical devices and combination products with an emphasis on gaining regional regulatory approval/clearance/license
• Prepare US, EU, and international submission sections (510k, IND, CTA, IMPD, NDA, BLA, MAA, etc.) for new products, product changes and information requests as required to ensure timely approvals for clinical studies and market release throughout the product life-cycle
• Author and review product submissions and assist with submission strategy and issues with regulatory bodies
• Provide guidance to global cross-functional teams to ensure documentation is accurately prepared with consideration to scientific rigor, accuracy, and clarity of presentation to support high quality global regulatory submissions
• Review change controls to determine impact and reportability to existing regulatory filings
• Supports EU RA office with complaints and Post Market Surveillance of marketed products
• Maintain proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• Other duties as assigned

• Bachelor's Degree in science, math, engineering, or related discipline required or
• Master's Degree in science, math, engineering, or related discipline preferred or
• PhD in science, math, engineering, or related discipline preferred or
• Advanced degree preferred

• Minimum 5 years of experience with Bachelor’s degree or
• Minimum 2 years of experience…