Opportunity to work as RA Intelligence Principal at West Pharmaceutical Services- Apply before 15th July 2024

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. By collaborating closely with its customers from concept to patient, West creates products that enhance the efficiency, reliability, and safety of the global pharmaceutical drug supply. Headquartered in Exton, Pennsylvania, West supports its customers with facilities in North and South America, Europe, Asia, and Australia. In 2016, West reported sales of $1.5 billion, reflecting the daily use of approximately 112 million of its components and devices, which are designed to improve healthcare delivery to patients worldwide.

Job Posting: RA Intelligence Principal – Materials

Job Description

Job Summary

The Principal, Regulatory Affairs, Intelligence, Materials will work independently, bringing extensive expertise in materials and their application in medical devices, pharmaceuticals, and combination products. This role is pivotal in ensuring regulatory compliance for materials, requiring a deep understanding of global regulatory frameworks, strong project management skills, and effective collaboration with cross-functional teams and external vendors. The successful candidate will support both internal and external customer regulatory requests.

Essential Duties and Responsibilities

• Surveillance Activities: Conduct research and communicate updated global chemical and material regulatory requirements that aid in the development, registration, submission, and post-marketing of West’s products and services. Areas of surveillance include chemicals, devices, pharmaceuticals, combination products, labeling, and packaging.
• Regulatory Intelligence: Research and convey the latest regulatory intelligence to internal stakeholders, contextualizing its impact on West’s portfolio and business. Ensure clear and effective communication of regulatory changes to drive necessary actions.
• Emerging Trends: Develop insights on emerging regulatory trends and communicate their implications to internal stakeholders and external customers through updates to Master Regulatory Plans, training sessions, presentations, white papers, etc.
• Industry Initiatives: Monitor, analyze, and recommend action plans for current and future industry initiatives, drafting public comments in response to regulations and guidance from regulators and health authorities.
• Cross-Functional Collaboration: Work with R&D, Quality Assurance, Clinical Affairs, and other departments to ensure regulatory alignment, including participating in project teams to provide regulatory guidance throughout the product lifecycle.
• Vendor Relations: Lead discussions with consultants and external vendors to assist in global regulatory strategies and participate in industry events, conferences, or working groups as applicable. Manage relationships with regulatory vendors, ensuring timely delivery of documentation and materials.
• Training and Awareness: Provide training to internal teams on regulatory requirements and updates related to pharmaceuticals, packaging, medical devices, and combination products. Maintain regulatory awareness through engagement with relevant trade associations, coalitions, and alliances.
• Additional Duties: Perform other duties as assigned.

Candidate Profile

• Education: Bachelor’s, Master’s degree, or PhD in science, math, engineering, or related discipline.
• Experience: Minimum of 8 years.
• Collaboration: Ability to work collaboratively across all levels of the organization to influence and persuade others.
• Presentation Skills: Experience in directly interacting and presenting to project teams, customers, and industry groups.
• Medical Device Knowledge: Demonstrated understanding of related medical device development and operations (e.g., manufacturing, process development, analytical, quality assurance).
• Skills: Strong negotiation, decision-making, written and verbal communication, timeline management, and leadership skills.
• Proactive Attitude: Self-motivated with the ability to work effectively and proactively.
• Team Environment: Ability to work collaboratively in a cross-functional team environment and adjust effectively to new work structures, processes, and cultures.
• Regulatory Competency: Competency in regulatory compliance, including ISO 13485 certified Quality Systems and international regulatory standards.
• Preferred Qualifications: Advanced degree, Regulatory Affairs Certification (R.A.C), and experience with pharmaceuticals, administration, and drug delivery systems.
• Travel: Must be able to travel up to 5–10% of the time for meetings, trainings, projects, and industry events.

Physical & Mental Requirements

• Ability to understand principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation confidentially.
• 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 to form general rules or conclusions.
• Ability to make informed decisions by considering relative risks and benefits.
• Ability to manage multiple long-term and short-term projects concurrently.
• Ability to work effectively as part of a team in cross-functional and/or matrix environments.
• Ability to be flexible with changing priorities and comply with evolving regulatory procedures.
• Ability to build strong internal and external relationships.
• Ability to thrive in a fast-paced environment.

Additional Information

• Experience: Minimum 8 years
• Qualification: Bachelor’s, Master’s degree, or PhD in science, math, engineering, or related discipline
• Location: Exton, Pennsylvania, US
• Industry Type: Pharma/ Healthcare/ Clinical research
• Functional Area: Regulatory Affairs
• End Date: 15th July 2024
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