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Title:  Director, Regulatory Affairs - Regulatory Systems (Remote)

Requisition ID:  43591
Date:  Nov 7, 2022
Location: 

Exton, Pennsylvania, US

Department:  Regulatory Affairs
Description: 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

This role serves as a key strategic partner and works closely with the broader regulatory matrix team to successfully publish and maintain regulatory documentation for West’s product portfolios to ensure documents are formatted in accordance with appropriate regulatory guidelines and style guides and transmit via both paper and electronic media to health authorities in the US, EU, China, and Rest of World.  This role is expected to develop strategies for publishing regulatory submissions and influence West’s regulatory processes and procedures.  With minimal supervision, the Director ensures timely and high-quality execution of all regulatory deliverables and ensures compliance with West and government requirements.  In addition, the Director manages other regulatory personnel and leads SharePoint structure and submission functionality within the Global Regulatory Affairs Unit. This position can accommodate a remote work location.

 

Essential Duties and Responsibilities:

  • Leadership role driving publishing and tracking of CMC dossiers and regulatory documentation [DMFs, Dossiers, MAFs, 510(k)’s, LOAs] for submission to Health Authorities in compliance with current regulations, guidelines and procedures for West’s elastomeric and medical device portfolios

  • Develop and maintain regulatory documentation databases or systems as well as technical documentation required for regulatory submissions and source documents

  • Proactively analyze changes in the regulatory environment and works closely with internal subject matter experts to assess the impact of regulatory policies on West's business goals

  • Works with global Regulatory Affairs colleagues to ensure regulatory activities and documents are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance to facilitate agency review/acceptance and comply with global regulations

  • Directs, advises, and guides Regulatory Affairs sub-team members on regulatory strategies and advises of changes in regulatory guidance that may impact the business

  • Participate and/or oversee direct interactions with health authorities to achieve desired outcomes

  • 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

  • Manage and continue building the team to submit high quality support to West's product portfolio and customers

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

  • Develop specific objectives and manage work assignments, with minimal supervision, in an effort 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

  • Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required

  • 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

  • Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). 

  • Experience directly interacting and presenting to project teams, customers, industry groups

  • 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:

  • Knowledge of West elastomer product portfolio

  • Experience directly interacting with government agencies

  • Previous work in a fee for service organization

  • Managerial experience with demonstrated track record of successfully managing high-performance cross-functional matrix teams in a complex organization

Travel Requirements:

 

Physical & Mental Requirements:

  • Ability to comprehend principles of math, science, and engineering

  • 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, 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 assess, plan, schedule and manage multiple projects, tasks, responsibilities and/or priorities 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

 

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 Apply.Accommodation@westpharma.com.  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.

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