Director, Regulatory Affairs, HF

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 Director is expected to perform with minimal supervision and is responsible for embedding human factors engineering principles to optimize West product attributes such as usability, safety, quality, and performance on West products. on robust human factors/usability studies to support West products and developing clear policies to drive action. This role serves as a key strategic partner with the R&D, QA, Operations, Commercial, Legal and Finance teams and works directly with the broader regulatory matrix team to ensure compliant usability. In addition, the Director manages other regulatory personnel, and provides support for global regulatory approvals (beyond US and EU), commercialized products, and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This role is responsible for driving continuous improvement in the day-to-day operations of the regulatory functions and seeks opportunities to continually enhance cross-functional effectiveness across the organization in line with corporate goals. They must proactively maintain an understanding of health authority guidelines, regulations, and best practice to establish regulatory strategy and shape the future regulatory requirements.

Essential Duties and Responsibilities:

• Provide strategic regulatory expertise and operational direction to management, internal, and external customers to ensure conformance with corporate requirements, government regulations, guidelines and industry standards as it relates to human factors/usability.
• Develop clear policies, processes, and trainings to embed a culture of regulatory compliance within West and with our partners.
• Lead a Regulatory team that designs and execute Human Factors studies to evaluate product user interface – including hardware, software, packaging, instructional material, and training.
• Collaborates with cross-functional stakeholders (Medical Device Labeling, Clinical, Quality Assurance and Research & Development) to ensure human factors inputs are considered in final labeling outputs.
• Lead efforts to proactively understand and embed the latest global regulations and guidance for human factors, including trends in enforcement and reimbursement policy. Directs, advises, and guides Regulatory Affairs and cross-functional leadership on regulatory strategies and impact to the West business.
• Identify and qualify vendors, tools, templates and systems to build efficiency for human factors study execution.
• Foster career growth opportunities through training, mentorship and guidance of direct reports, RA staff and peers to define and achieve personal, departmental, and corporate objectives.
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
• Other duties as assigned.

Basic Qualifications:

• Education: Bachelor’s, Master’s degree or PhD in science, math, engineering, or related discipline
• Experience: Bachelor’s with 10+ years; Master’s degree/PhD 5-8 years regulatory/pharmaceutical experience
• Able to work collaboratively across all levels of the organization to influence and persuade others.
• Experience directly interacting and presenting to project teams, customers, industry groups
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Strong negotiation and decision-making skills
• Excellent written and verbal communication, timeline management and leadership skill
• Self-motivated with a proactive attitude and the ability to work effectively

Preferred Knowledge, Skills and Abilities:

• Excellent interpersonal, communication and listening skills.
• Knowledge of regulatory guidance documents and standards related to human factors, combination products, delivery system and design controls.
• Experience in medical device regulatory affairs and/or design control process, direct interactions with regulatory agencies and management of regulatory support systems.
• Regulatory compliance competency including Quality Systems
• International regulatory competency
• Advanced degree
• Regulatory Affairs Certification (R.A.C)

Travel Requirements:

• Must be able to travel up to 5 – 10 % of the time (Vendors, meeting, trainings, projects, industry events)

Physical and Mental Requirements:

• Sedentary work environment, exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions. Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally.
• Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

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.