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West Pharma Director Regulatory Affairs United States, Pennsylvania, West Whiteland Township 70973016
Today
Essential Duties and Responsibilities
- Provide strategic leadership and oversight to ensure regulatory compliance across the product lifecycle.
- Manage highly complex regulatory projects, including drug-device combination products.
- Drive pre-market and post-market regulatory initiatives for successful product commercialization and compliance.
- Collaborate with internal teams such as Research and Development, Clinical, QA, Operations, Commercial, Legal, and Finance to execute key projects.
- Manage and support regulatory personnel in accordance with West and government requirements.
- Assist with US, EU, and ROW clinical programs and regulatory approvals.
- Enhance cross-functional effectiveness and drive continuous improvement in regulatory and quality operations.
- Maintain an up-to-date understanding of health authority guidelines and regulations to shape future regulatory strategies.
Education
- Bachelor's Degree In science, math, engineering, or related discipline required
- Master's Degree In science, math, engineering, or related discipline preferred
- PhD In science, math, engineering, or related discipline preferred
Work Experience
- Bachelor’s Degree with 10+ years; Master’s Degree/PhD 5-8 years regulatory/pharmaceutical experience required
- Experience directly interacting and presenting to project teams, customers, industry groups required
Preferred Knowledge, Skills and Abilities
- Able to work collaboratively across all levels of the organization to influence and persuade others.
- 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
- Excellent interpersonal, communication and listening skills.
- Knowledge of regulatory guidance documents and standards related to human factors, combination products, delivery system and design controls.
- Experience in medical device regulatory affairs and/or design control process, direct interactions with regulatory agencies and management of regulatory support systems.
- Regulatory compliance competency including Quality Systems
- International regulatory competency
- Advanced degree
License and Certifications
- Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Upon Hire preferred
Additional 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).
Physical Requirements
Sedentary-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.
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