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Title:  Specialist, Regulatory Project Management (Remote)

Requisition ID:  52350
Date:  Sep 23, 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 Regulatory Project Management (RPM) role is primarily responsible for management of regulatory affairs projects associated with West’s global portfolio of packaging components, medical devices, and combination products. This role will work collaboratively with cross-functional teams and lead the regulatory team through all project phases to support regulatory filings including Technical Documentations & Notified Body Opinion Letters under EU MDR, Premarket Notifications, and Master Files (DMF/MAF) associated with pharmaceutical partner’s NDAs, ANDAs, and BLAs.  Requirements include maintaining 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 stakeholders in line with defined regulatory plans.This position offers an opportunity to work from a remote location. Preference will be given to candidates residing near Scottsdale, AZ or Exton, PA.

 

Essential Duties and Responsibilities:

  • Independently manage regulatory project lifecycle(s) including pre-submission, submission, post-submission, and post-approval maintenance cycles
  • Provide project management inputs on immediate and long-term global regulatory strategies
  • Support internal and external discussions to understand project funding, allocate resources, and propose timelines for medical device and combination product applications
  • Collaborate with cross-functional project manager(s) and SMEs to align on essential deliverables required for global submissions
  • Establish and manage regulatory action plans in accordance with the project scope and timeline to achieve timely, high-quality global regulatory submissions and responses to information requests
  • Implement project tools such as Gantt charts, issue logs, and risk registers to deliver performance metrics and other critical information to stakeholders
  • Schedule and lead team meetings, draft agendas, and capture and distribute meeting summaries
  • Ensure regulatory dossiers are completed in compliance with current and changing regulations, health authority guidelines, and industry standards to achieve regulatory approvals
  • Provide project management oversight, form mitigation plans for submission risks, and escalate issues as needed
  • Use data-driven decision-making processes to develop and adjust regulatory action plan for continuation, acceleration, and reprioritization
  • Support Regulatory Workstream meetings with West’s clients to review and align with NDA/ANDA/BLA/MAA filing strategies
  • Manage post-approval submission amendments and annual reporting for regulatory compliance
  • Challenge current processes and develop systems to continuously improve and drive change
  • Other duties as assigned

Basic Qualifications:

  • Education: Bachelor's in related discipline or equivalent experience
  • Experience: Bachelor’s with 3-5 years relevant project management experience in pharmaceutical or medical device field

 

Preferred Knowledge, Skills and Abilities:

  • Master’s degree/PhD 1-2 years relevant experience
  • Working knowledge of medical device regulatory affairs, design control process, and management of regulatory support systems is a plus
  • Proven ability to lead projects in a cross functional team environment
  • Experience in managing resource requirements
  • Strong knowledge of the medical device design control process and relevant regulations and standards
  • Excellent interpersonal, communication and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts
  • Possesses technical skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). 
  • Excellent written and verbal communication, organizational, timeline management and leadership skill
  • Experience utilizing Microsoft Office products such as MS Project and Excel
  • Self-motivated with a proactive attitude and the ability to work effectively
  • Experience in global regulatory submissions of Class I and II medical devices
  • Experience building detailed submission plans and analyzing technical requirements
  • Excellent interpersonal, communication and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts
  • Advanced degree 
  • R.A.C certification(s)

 

Travel Requirements:

  • Must be able to travel up to 5% of the time

 

Physical & Mental Requirements:

  • Comprehend principles of math, science, engineering, and medical device use
  • Handle technical reports, drawings, specifications, proprietary documentation with a high degree of confidentiality
  • 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
  • Review, collate, describe, and summarize scientific and technical data
  • Organize complex information and combine pieces of information to form general rules or conclusions. 
  • Utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one
  • 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
  • Be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams
  • Be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally
  • Work independently in a fast-paced environment
  • 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.
  • Maintain the ability to work well with others in a variety of situations
  • Ability to work in an office. May need to stand or sit for extended periods of time
  • Communication, quick decision making, interpreting data, reading, or writing - must be able to express or exchange ideas with team members
  • Must be able to understand direction and adhere to established procedures
  • Read and interpret data, information and documents
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Demonstrates enthusiasm, takes accountability and drives for results

 

 

 

 

 

 

 

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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