Job Summary:

The Director, Regulatory Affairs serves as the global regulatory lead for combination products and RA business development. This role serves as a key strategic partner with the development and commercial teams and works closely with the broader regulatory matrix team to conceive and deliver successful registration and life-cycle management of standard and technologically complex combination products. The Director will lead cross-functional internal activities and work directly with external customers and health authorities to plan and assist with ANDA, NDA, BLA, and OUS Marketing Applications. This role is responsible for driving continuous improvement in the day-to-day operations of product development and Regulatory Affairs, seeking opportunities to continually enhance cross-functional effectiveness across the organization in line with corporate goals. They must proactively maintain an understanding of health authority guidelines, regulations, and best practices to establish regulatory strategy and shape future government regulatory requirements. The Director manages regulatory professionals and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position can accommodate a remote work location.

Essential Duties and Responsibilities:

• Lead and execute the development and implementation of global CMC regulatory strategy supporting both clinical and commercial combination products associated with West’s delivery systems and future technologies
• Design and execute an effective global regulatory strategy for combination products in alignment with the overall development plan and enterprise goals including but not limited to communicating strategic direction, risk mitigation strategies and lead efforts to monetize Regulatory Affairs capabilities
• Provide and drive strategic and global CMC regulatory direction and documentation for assigned projects covering pre and post market registration activities
• Anticipate, identify, and communicate regional regulatory risks to management and cross-functional teams and advise of changes in regulatory guidance that may impact the business
• Ensure that all regulatory activities and documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance to facilitate agency review and acceptance
• Prepare and lead team for meetings and direct interactions with health authorities and external customers to achieve desired outcomes
• Serve as the global regulatory lead on cross-functional project teams collaborating with R&D, Operations, Quality, and key stakeholders internal and external to the company
• Advise and guide on regulatory strategy, regulations, and risks that may impact global registrations supporting projects and development agreements pertaining to West’s delivery systems
• Provide the business development team with guidance and critical evaluation of potential product opportunities, in support of strategic partnering and licensing activities
• Champion continuous improvements for increasing efficiency and delivering high quality regulatory submissions and to meet business objectives
• Foster career growth opportunities through training, mentorship and guidance of direct reports, RA staff and peers to define and achieve personal, departmental, and corporate objectives
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures

Basic Qualifications: 

• Education:  Bachelor’s, Master’s degree or PhD in science, math, engineering, or related discipline
• Experience:   Bachelor’s with 10+ years; Master’s degree/PhD 5-8 years supporting medical devices and/or drug/combination products.
• Global experience with subject matter expertise in drug/device combination product registration process lifecycle
• Demonstrated understanding of all phases of combination products development and lifecycle management related pharmaceutical operations e.g., CMC – (formulation/process development, manufacturing, analytical sciences, QA/QC), non-clinical, clinical 
• US Class II and EU Class IIa device experience and knowledge of US FDA regulations (Title 21) and EU MDR (2017/745)
• Advanced knowledge of 21 CFR210/211/820 and ISO 13485
• Experience directly interacting with government agencies
• Able to work collaboratively across all organizations in using internal SMEs to influence Agency guidance and regulations
• Experience directly interacting and presenting to project teams, customers, industry groups
• Possesses management and technical leadership skills
• 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
• Experience with US De Novo process and Class III device submissions, including IDE and software-containing devices and medical device capital equipment and IEC 60601-1:2005
• Holds a Doctor of Pharmacy degree
• Previous work in a fee for service organization.
• Understanding of clinical science associated with medical devices and combination products
• Experience with consultative selling of regulatory services for one of the following applications: medical devices and combination product development and commercialization.
• Managerial experience with demonstrated track record of successfully managing high-performance cross-functional matrix teams in a complex organization.
• International regulatory competency

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.