West Pharma Director RA Advertising & Promotion 

United States, Pennsylvania, West Whiteland Township 

704540481

Job Summary:

The Director, Regulatory Affairs, Advertising & Promotion is responsible for strategic direction and regulatory compliance on all product claims by providing sound regulatory advice that minimizes the risk of regulatory and legal action, competitively positions marketed products, and is consistent with applicable global regulations and West corporate policies.In addition, theprovides support for US, EU and ROW clinical programs and regulatory approvals in compliance with West Pharmaceutical Services, Inc. (West) and government requirements.This role is responsible for driving continuous improvement in the day-to-day operations of the regulatory and quality functions and seeks 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 practice to establish regulatory strategy and shape the future regulatory requirements.

Essential Duties and Responsibilities:

• Provide strategic regulatory expertise and operational direction to management, internal, and external customers to ensure conformance with corporate requirements, government regulations, guidelines and industry standards as it relates to promotional compliance and product claims.Develop clear policies, processes, and trainings to embed a culture of regulatory compliance within West and with our partners.
• Serve as internal expert and primary regulatory reviewer/approver for all externally facing West content (website, publications, presentations, blog posts, partner content, etc.) to ensure compliance with applicable global regulations, policies, and guidance.
• Lead efforts to proactively understand and embed the latest global regulations, guidance, and enforcement trends for advertising and promotional labeling.Direct, advise, and guide Regulatory Affairs and cross-functional leadership on regulatory strategies and impact to the West business.
• Evaluate and assess claims generation strategies for new products, leveraging scientific knowledge and substantiation criteria
• Develop and conduct training for internal and external stakeholders as needed to maintain compliance with evolving regulatory requirements
• Provide strategic input to product development and commercial teams to support flexible and viable claims strategies while championing promotional compliance
• Identify and qualify vendors, tools and systems to build efficiency for promotional material reviews and collateral lifecycle management.
• Adhere to all applicable government and West regulations, best 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 10+ years; Master’s degree/PhD 5-8 years regulatory/pharmaceutical experience
• 3+ years direct experience leading global promotional labeling reviews, including demonstrated experience with digital and social media platforms
• 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
• Excellent interpersonal, communication and listening skills.

Preferred Knowledge, Skills and Abilities:

• Exceptional ability to independently problem solve, negotiate, influence, and collaborate cross-functionally while maintaining a risk-based mindset
• Expertise in US and OUS regulations for medical device advertising and labeling
• Experience in medical device regulatory affairs, direct interactions with regulatory agencies, and management of regulatory support systems.
• 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 (Vendors, meeting, trainings, projects, industry events)

Physical and Mental Requirements:

• Sedentary work environment, exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• 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).