Sr. Specialist Regulatory Affairs, MD

Sr. Specialist Regulatory Affairs

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. 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 Regulatory Affairs Sr. Specialist is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, Post Market Submissions, China NMPA Registrations, Technical Documentation for CE Marking, 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 government 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 Transfer Devices 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, product changes and post-market updates as required to ensure timely approvals for market release and file maintenance
• Works with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations
• Provide leadership to product development teams for regulatory issues and questions
• Provide support to market-released products as necessary, including reviewing labeling, promotional material, product / manufacturing process changes, post-market reporting and documentation
• Establish and maintain good working relationships with agency personnel
• Compile and maintain regulatory databases or systems as well as technical documentation required for new or modified products
• Create documentation in response to customer regulatory requests which include regulatory letters, technical packages, etc.
• 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

Education : Bachelor's, Master's degree or PhD in science, math, engineering, or related discipline. Experience : Bachelor's with 5+ years; Master's degree / PhD with 3+ years of medical device, pharmaceutical or regulatory experience.

Work Experience : Bachelor's with 5+ years of medical device, pharmaceutical or regulatory experience. Master's degree / PhD with 3+ years of medical device, pharmaceutical or regulatory experience.

Preferred Knowledge, Skills and Abilities :

License and Certifications : Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

Travel Requirements : 10% : Up to 26 business days per year

Physical Requirements : Sedentary-Exerting up to 10lbs / 4kgs of force occasionally, and / or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements :

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and / or drug screening.