This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.Job SummaryThe Principal, Regulatory Affairs - Intelligence, Pharmaceutical is a highly experienced and strategic professional who operates with minimal supervision. This role requires deep expertise in global regulatory frameworks, with a specialized focus on containment systems (i.e., primary packaging), pharmaceutical manufacturing and handling, and regulatory requirements applicable to drugs and drug constituents of combination products. The successful candidate will translate regulatory intelligence into informed business decisions, build internal capability, and strengthen West's external technical presence through thought leadership and policy advocacy.
Essential Duties and Responsibilities- Perform surveillance activities by researching, identifying, analyzing, and communicating evolving global regulatory requirements that impact development, registration, submission, post-marketing, and lifecycle management of West's products and services. Surveillance areas include, but are not limited to, primary packaging; pharmaceutical manufacturing, handling, and quality management systems; enforcement trends; and other requirements for pharmaceutical and combination products (e.g., compendia).
- Synthesize regulatory intelligence and emerging trends into actionable insights for internal stakeholders and external customers through Master Regulatory Plans, trainings, presentations, white papers, technical publications, and other communication tools as appropriate. Ensure timely communication of regulatory changes that impact product development, compliance, and lifecycle management.
- Collaborate with R&D, Quality Assurance, Clinical, Product Management and other functions to provide regulatory guidance throughout the product lifecycle and ensure alignment with applicable regulatory requirements.
- Provide internal training and build organizational capability on regulatory requirements and updates related to containment systems, pharmaceutical manufacturing and handling, and applicable pharmacopeial standards.
- Monitor and evaluate regulatory initiatives; partner with subject matter experts to develop aligned public comments and position statements on proposed regulations and guidance; and support external engagement on policy and standards matters relevant to West's products, services, and One West objectives.
- Maintain a high level of regulatory awareness and strong business acumen by engaging with external experts, vendors, trade associations, coalitions, standards-setting bodies, and industry working groups to support global regulatory strategies; representing West externally on drug containment and handling topics; communicating key learnings internally to drive proactive regulatory response; and identifying opportunities for West to contribute to broader policy and standards discussions in alignment with One West objectives.
- Manage relationships with regulatory vendors, ensuring timely delivery of documentation and materials.
- Perform other duties as assigned, contributing to the broader regulatory affairs strategy and compliance efforts.
Education- Bachelor's, Master's degree or PhD in science, math, engineering, or related discipline
Work Experience- Bachelor's degree and minimum 8 years of pharmaceutical experience or equivalent experience; Master's degree/PhD and minimum 5 years of regulatory/pharmaceutical experience
- Demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality systems and assurance, handling)
Preferred Knowledge, Skills and Abilities- Global regulatory competency
- Advanced degree
- Experience with transfer devices and drug delivery systems preferred
- Experience with large molecules (e.g., biologics) preferred
- Able to comply with the company's safety and quality policies at all times
License and Certifications- Regulatory Affairs Certification (R.A.C.) preferred
Travel Requirements10%: Up to 26 business days per year
Physical RequirementsSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements- Comprehend principles of math, science, engineering, and medical product use.
- Handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
- 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.
- Review, collate, describe, and summarize scientific and technical data.
- Organize complex information and combine pieces of information to form general rules or conclusions.
- Utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
- 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.
- 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.
- Build strong relationships both internally and externally. Ability to work in a fast-paced environment.
- Able to work collaboratively across all levels of the organization to influence action and reach consensus.
- Experience directly interacting and presenting to project teams, customers, and industry groups.
- Strong negotiation and decision-making skills.
- Excellent written and verbal communication skills.
- Proven leadership capabilities with a strong track record in time management, project coordination, and driving cross-functional initiatives to successful completion.
- Self-motivated with a proactive attitude and the ability to work effectively.
- Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
- 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).
- Position operates in a professional office environment. May stand or sit for extended periods of time.
- Able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
- Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
- Able to multi-task, work under time constraints, problem solve, and prioritize
- Ability to make independent and sound judgments
- Observe and interpret situations, analyze and solve problems
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