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Senior Regulatory CMC Specialist

Requisition ID:  34823
Date:  Sep 12, 2021
Location: 

Exton, Pennsylvania, US

Department:  Regulatory Affairs

 

 

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 role is responsible for coordinating and authoring regulatory submissions for West’s products and processes.  This position includes supporting internal and external customer regulatory requests and maintaining knowledge of the current US and international regulations/guidelines/policies applicable to West’s products and services. 

 

Essential 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 requests 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 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. 
  • Other duties as assigned

 

Basic Qualifications: 

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

 

Preferred Knowledge, Skills and Abilities: 

  • 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).
  • Knowledge of West elastomer product portfolio
  • 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. 
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description 
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target 
  • Able to comply with the company’s safety and quality policy at all times

 

Travel Requirements:

  • Must be able to travel up to 5-10% of the time 

 

 

 

 

 

 

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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