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Title:  Principal Regulatory Project Manager

Requisition ID:  63307
Date:  Feb 2, 2024
Location: 

Exton, Pennsylvania, US

Department:  Legal
Description: 

 

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:

In this role, you will be expected to perform with independence and is primarily responsible for management of regulatory affairs projects associated with West’s portfolio of medical devices and combination products. The individual is required to work collaboratively with cross functional teams to coordinate the regulatory work stream elements to support high-quality submissions, including Premarket Notifications, Master Files, 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.
  • Identify project and submission risks, implement mitigation strategies, manage issues and escalation to closure and resolution, and presents actionable recommendations for improvement.
  • Work closely with R&D, quality assurance, clinical affairs, and manufacturing teams to ensure regulatory strategy and considerations are integrated into product development and lifecycle management.
  • Support regulatory department strategic planning, development and implementation of consistent project tools, templates and reports that deliver informative performance metrics and other critical information to stakeholders.
  • Remain current on evolving regulations, guidelines, and industry trends to inform regulatory strategies and actions.
  • Communicate and participate in formal interactions with customers and regulatory agencies, as required, to fulfil business objectives.
  • Prepare for and manage regulatory audits and inspections by authorities, ensuring all findings or nonconformities are timely addressed and submitted to authorities.  
  • Manage the preparation, review, and submission of complex regulatory dossiers, including regulatory filings, information request responses, and post-market surveillance reports/compliance reports.
  • Maintain effectiveness when experiencing major changes in work responsibilities, new work structures, processes, requirements, or cultures.
  • Assess and identify need for process improvement and lead change initiatives within the organization.

Basic Qualifications: 

  • Education: Bachelor's or Master’s degree in science, engineering, or related discipline
  • Experience: Bachelors with 8 years; or Master’s degree with 3-5 years’ experience in the area of development, scale-up and registration of regulated medical devices and combination products

 

Preferred Knowledge, Skills and Abilities:

    • Proficiency in using project management software and regulatory tools.
    • 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 analytical, critical thinking and problem-solving skills.
    • Strong leadership and team management abilities and 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
    • 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)
    • Proven track record of successful regulatory submissions and interactions with regulatory authorities.
    • Experience in regulated combination product, medical device development, registration of class I and class II medical devices, and profound knowledge of industry-specific regulations and standards.
    • Exceptional project management skills, including planning, execution, and budget management.
    • Regulatory Affairs Certification (R.A.C) and/or Project Management Professional Certification (PMP)
    • Fundamental knowledge of Quality Management System (QMS), ISO 13485, 21 CFR Part 820.

 

Travel Requirements:

  • Must be able to travel up to 10% of the time.

 

Physical and Mental Requirements:

  • Sedentary 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

 

 

 

 

 

 

 

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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