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Title:  Regulatory Affairs Project Manager (Remote)

Requisition ID:  36206
Date:  Oct 7, 2021
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.

 

This Regulatory Affairs Project Manager (RPM) role is expected to perform with independence and is primarily responsible for the management of regulatory affairs projects associated with West’s portfolio of medical devices and combination products.  Work collaboratively with cross-functional teams to coordinate the regulatory workstream elements to support submissions, including Premarket Notifications, Technical Documentation for CE Marking or those associated with NDAs, BLAs, MAAs.  Maintain knowledge of current international regulations/guidelines/policies applicable to West’s products and services.  This position includes providing regulatory guidance and updates to internal and external customers in line with defined regulatory plans.

 

Essential Duties and Responsibilities:
•    Independently analyze, plan and track project phases and activities, and communicate strategic direction regarding timelines/milestones/risks/goals on a regular basis to the leadership team and key stakeholders
•    Identifies operational risks with projects and submissions, implements mitigation strategies, and manages issues to closure
•    Consistently and proactively communicate with R&D, Operations and Quality representatives and other functions to develop detailed project plans and timelines, to meet clients’ needs, and to achieve project milestones and project success
•    Gather regulatory requirements and understand regulatory strategy to determine project resources needed, costs and timelines
•    Author and review development agreements and contracts for regulatory projects
•    Leverage project management software (such as MS project) to develop and maintain detailed project schedules that meet the objectives associated with the defined scope and schedule. 
•    Coordinate with complex cross-function teams with guidance to ensure timely completion of tasks and deliverables that adhere to schedules. 
•    Review and analyze project data and information to provide status updates, insights, conclusions and actionable recommendations. 
•    Schedule and lead team meetings, draft agendas and capture and distribution meeting summary  
•    Implements and enables processes for consistent issue escalation and resolution
•    Effectively utilize all available support staff
•    Support the development and implementation of consistent project tools, templates and reports that deliver informative performance metrics and other critical information to stakeholders
•    Maintain effectiveness when experiencing major changes in work responsibilities or environment
•    Adjust effectively to work within new work structures, processes, requirements, or cultures.
•    Challenge processes remain open to ideas and changes to continuously improve and seek better alternatives and drive change.
•    Adhere to all applicable government and West regulations, practices and procedures to maintain compliance. 
•    Successfully multi-task amongst several competing initiatives
•    Contribute to the development and delivery of training to team members as applicable

 

Basic Qualifications:
•    Education: Bachelor's or Master’s degree in science, engineering or related discipline
•    Experience: Bachelors with 4-6 years; or Master’s degree with 2-3 years experience in the area of development, scale-up, and registration of regulated medical devices and combination products 
•    Proven ability to lead projects in a cross-functional team environment 
•    Knowledge of combination product and medical device design control process and management of regulatory support systems 
•    Experience in regulated combination product and medical device development and registration of class I and class II medical devices
•    Expertise with managing resource requirements 
•    Strong MS Project user, understand dependencies, critical path 
•    Excellent interpersonal, communication and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
•    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, organizational, timeline management and leadership skill
•    Self-motivated with a proactive attitude and the ability to work effectively

 

Preferred Knowledge, Skills, and Abilities:
•    Demonstrated experience with tools supporting FMEA, risk analysis planning and prioritization. 
•    Project management experience in a regulated industry 
•    International regulatory competency
•    Advanced degree 
•    R.A.C certification(s)
•    Experience with administration and drug delivery systems preferred

 

Travel Requirements:
•    Must be able to travel up to 5-10% of the time (meetings, trainings, projects)
 

 

 

 

 

 

 

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 kimberley.eby@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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