Description
This role is hybrid (3 days onsite) in Exton, PA. Candidates applying must be currently residing within a 50-mile commutable radius to the location or willing to relocate to the job location.
Who We Are
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, Regulatory Affairs, Intelligence is expected to perform with minimal supervision and is responsible for strategic implementation of a regulatory intelligence network that encompasses separate regulatory functions, cross-functional team members and external partners to provide daily monitoring of the regulatory landscape as it relates to West products. Intelligence gathered will then be deployed to the organization through effective notifications, master regulatory plans, coordinated trainings.
- The Director will be responsible for managing regulatory personnel, overseeing the development of a knowledge management system, and identifying key regulatory intelligence tools to further the team’s capabilities.
- T he Director will drive action to ensure updated information is incorporated into revised policies and/or procedures.
Essential Duties And Responsibilities
- Develop strategic processes for regulatory surveillance activities including active daily monitoring, comment solicitation, and managing critical suppliers of regulatory intelligence inputs. Lead a regulatory team that monitor, analyze, and outline action plans for current and future industry initiatives and draft public comments in response to regulations and guidance issued by regulators and health authorities.
- Proactively research and articulate the latest regulatory intelligence to internal cross-functional stakeholders (including, but not limited to, Regulatory Affairs, Clinical, Quality Assurance, Research & Development, and Customers) . Contextualize the scope and applicability to West’s portfolio and ensure that changes to applicable regulations are clearly and effectively communicated to drive effective impact assessments and action.
- Convert identified applicable regulatory intelligence into documented master regulatory plans, robust policy documentation, procedures, white papers and training, as applicable, to ensure compliance.
- Oversee information sharing in the form of periodic meetings with Regulatory Management and key stakeholders to provide trends, actions, and owners on major regulatory updates.
- Provide proactive support to customers and external stakeholders on emerging regulatory trends through blogs, webinars, publications and/or industry presentations.
- Identify and qualify vendors, tools, and systems to build efficiency in regulatory intelligence and knowledge management activities.
- Build influence through engagement in relevant trade associations, coalitions, and alliances.
- 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.
- Adhere to all applicable government and West regulations, best practices, and procedures to maintain compliance. Work with authors to revise, draft or update documents as needed to ensure compliance.
- 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 and regulatory authorities.
- 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
- Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
Preferred Knowledge, Skills And Abilities
- Regulatory compliance competency including Quality Systems
- International regulatory competency
- Advanced degree
- Regulatory Affairs Certification (R.A.C)
- ISO 13485 Auditor Certification
- Experience with administration and drug delivery systems preferred.
Travel Requirements
- Must be able to travel up to 5 – 10 % of the time (meeting, trainings, projects, industry events)
Physical & Mental Requirements
- 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 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.
