Sr. RA Specialist

Requisition ID: 64216
Date: Feb 9, 2024
Location:

Ra'anana, Central district, IL

Department: Regulatory Affairs
Description:

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.

Job Summary:

The Regulatory Affairs Sr. Specialist is expected to perform with minimal support and is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and applicable regulatory requirements. This position includes supporting internal and external customer regulatory requests.

Essential Duties and Responsibilities:

Develop and implement medical device regulatory strategies for West’s Administration and Safety Systems portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner

Author and review US, EU, Japan, China, and additional international submissions with guidance for new products and product changes as required to ensure timely approvals for market release

Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations

Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation

Work with RA team to build Regulatory strategies, including worldwide requirements lists, for administration and safety system development platform

Provide leadership to product development teams for regulatory issues and questions

Provide support to market-released products as necessary, including reviewing manufacturing process changes and documentation for changes requiring regulatory approval

Establish and maintain good working relationships with regulatory agency personnel

Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products

Create documentation in response to customer and regulatory agency requests, including regulatory letters, technical packages, etc.

Work to continuously improve regulatory databases, sharepoint sites and processes

Author, review and approve white papers, presentations and documentation to educate internal teams and customers on regulations impacting West products marketed in China and Asia Pacific regions as needed

Write or update standard operating procedures, work instructions, or policies

Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers

Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals

Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures

Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change

Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance

Other duties as assigned

Basic Qualifications:
Education: Bachelor's degree in chemical engineering/materials engineering/biomedical engineering/degree in life sciences
Experience: at least 5 years in similar roles.
Fluent in Hebrew and English: Writing/ Reading/ Speaking

Preferred Knowledge, languages, Skills and Abilities:

Ability to manage projects in a matrix structure
Ability to work under pressure.
Excellent Interpersonal communication.
Ability to work independently self-directed.
Analytical problem-solving skills.
Creativity.
Excellence learning skills.
Excellent organizational skills including the ability to efficiently evaluate, prioritize and handle multiple and changing projects.
Experience with Windows office and Solid works.

Travel Requirements:

Must be able to travel up to 5 % of the time

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected]. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.