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Title:  Sr. Specialist, Regulatory Project Management

Requisition ID:  56102
Date:  Nov 2, 2022
Location: 

Exton, Pennsylvania, US

Department:  Legal
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.

 

POSITION SUMMARY: This role is responsible for coordinating and authoring regulatory submissions for West’s products and processes.  Address customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to West’s products and services.

 

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Complete moderately complex regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of CMC dossiers for submission to Health Authorities [DMFs, MAFs, 510(k)’s] in compliance with regulations, guidelines and procedures.
  • Communicate directly with Regulatory agencies in response to request for information, regulatory inquiries or in support of customer regulatory filings.
  • Participate on project development teams and provide regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.
  • Review technical project documentation such as protocols, summary reports, regulatory plans, certifications, correspondences, and external communications, as needed, providing guidance and direction where applicable.
  • Provide customers with West product related information and data as required for regulatory submissions to European and Rest of World agencies.
  • Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
  • Train, mentor and/or guide the activities of direct reports, RA staff members and peers to define and achieve personal, departmental and corporate objectives, as applicable.
  • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.
  • Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to West’s products and business.
  • Develop specific objectives and manage work assignments, with minimal guidance, 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.

 

REQUIRED QUALIFICATIONS:

  • Education:  Bachelor, Master’s or PhD degree in related discipline
  • Experience: Bachelors with 3-5 years; or Master’s / PhD degree with 1-3 years regulatory/pharmaceutical experience.

 

PREFERRED QUALIFICATIONS:

  • Knowledge of West elastomer product portfolio
  • Experience in regulatory CMC with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). 
  • Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
  • Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.

 

PHYSICAL & TRAVEL REQUIREMENTS:  

  • 5 - 10% (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 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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