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Title:  Principal, Regulatory Affairs, Marketing and Advertising (Remote)

Requisition ID:  45885
Date:  Apr 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:

The Principal, Regulatory Affairs, Advertising and Marketing is expected to perform with minimal supervision and is responsible for providing sound regulatory advice that minimizes the risk of regulatory and legal action, competitively positions assigned products, and is consistent with applicable global regulations and West corporate policies.This position can accommodate a remote work location.

 

Essential Duties and Responsibilities:

  • Serve as internal expert and manage global regulatory activities associated with review, approval and lifecycle management of promotional materials for West’s marketed and development products including (but not limited to) medical devices, combination products, software as a medical device (SaMD), and pharmaceutical packaging.
  • Serve as the primary regulatory reviewer/approver for all external facing West content (website, publications, presentations, blog posts, etc.) to ensure compliance with applicable global regulations, policies and guidance.
  • Research and articulate the latest regulatory policy intelligence on marketing/promotion to internal stakeholders and contextualize the impact on West portfolio and business.  Ensure that changes to applicable regulations are clearly and effectively communicated to drive action.
  • Work with RA team to build regulatory strategies and worldwide requirement lists for promotion of West’s portfolio
  • Collaborate closely with industry groups and associations on joint advocacy around marketing and promotion.
  • Work closely with global RA team members to share knowledge and align on best practices.
  • Contribute to regulatory documentation databases or systems as well as technical documentation required for regulatory policy and intelligence libraries
  • Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.  Work with authors to revise, draft or update documents as needed to ensure compliance.
  • Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
  • Other duties as assigned

 

Basic Qualifications: 

  • Education:  Bachelor’s, Master’s degree or PhD in science, math, engineering or related discipline
  • Experience:   Bachelor’s with 4-6 years; Master’s degree/PhD 3-4 years medical device regulatory experience
  • Able to work collaboratively across all levels of the organization to influence and persuade others.
  • Experience directly interacting and presenting to project teams, customers, industry groups
  • 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, timeline management and leadership skill
  • Self-motivated with a proactive attitude and the ability to work effectively

 

Preferred Knowledge, Skills and Abilities:

  • Regulatory compliance competency including Quality Systems
  • International regulatory competency
  • Advanced degree 
  • Regulatory Affairs Certification (R.A.C)

 

Travel Requirements:

  • Must be able to travel up to 5 – 10 % of the time (meeting, trainings, projects, industry events)

 

Physical & Mental Requirements:

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.

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).

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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