To support and maintain both PDI and Nice-Pak strategic business objectives via regulatory registrations, filings and compliance for OTC, drug and medical device products for the US, Canada, EU and other global regulatory bodies. Will ensure full regulatory support and compliance with applicable ICH, federal and state regulations regarding product, labeling, policies and practice so that the business can respond appropriately.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
LEADERSHIP & MENTORING a. Lead, Direct and influence the PDI and NP technical teams to support and develop new products in order to grow and expand the PDI/NP business and product line. This will be done through internal development and by licensing and acquisition. b. Develop, Lead and influence internal and external cross functional teams to ensure the necessary scientific data, studies, documentation, interpretations and information are available in a timely manner to support regulatory requirements. c. Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs.
REGULATORY REGISTRATIONS & FILING a. Develop, influence and implement regulatory strategies to obtain new regulatory approval and registrations and to defend existing product lifecycle and registrations. b. Plan, coordinate, and prepare regulatory/registration applications, scientific documents and information for new products, Maintain compliance with all regulatory requirements for products that fall under their responsibility c. Influence regulatory agencies to obtain timely approval of pending applications and registrations.
PROJECT MANAGEMENT a. Work directly with and influence regulatory agencies to obtain timely approval of pending applications and registrations. Help educate them on PDI/NP products to ensure that the company’s interests are protected and represented in the development of new regulations. b. Facilitate favorable regulatory outcomes through establishing appropriate internal and external meetings, advising on appropriate data generation, and negotiation of requirements, labeling and risk mitigation.
REGULATORY COMPLIANCE/INTELLIGENCE a. Participate in Trade associations to protect PDIs interest and products. b. Maintain knowledge of current ICH, GMP, GLP and GCP regulations and contact with key regulatory authorities. Must have experience with eCTD submissions and CTD format. c. Ensure that product-labeling claims, advertising are within regulatory compliance with applicable country laws and regulation d. Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs.
PERFORMANCE MEASUREMENTS 1. Project management 2. Regulatory Compliance 3. Number of Regulatory Submissions 4. Number of Regulatory Approvals 5. New Product Launches 6. Team Development
EDUCATION/CERTIFICATION: BS, MS or Ph.D in chemistry, biology, microbiology, nursing, pharmacy or life sciences or equivalent.
REQUIRED KNOWLEDGE: • Knowledge and working experience of the regulatory and registration process of pharmaceutical and/or Medical Device products. • Scientific knowledge of applicable area(s) to the regulatory process for registration of new drugs, OTC and Medical devices for both US, Canada, EU and global markets.
EXPERIENCE REQUIRED: • Must have a minimum of 8 years of pharmaceutical or biotech Industry experience. • Must have at least 5 years of management/supervisor experience. • Must have experience with eCTD submissions and CTD format. • Experience with interfacing with both the center and District FDA offices • Proven track record for developing others
SKILLS/ABILITIES: • Ability to construct persuasive scientific documents to support/ defend regulatory strategies and registrations. • Highly developed written and oral communication skills • Proficiency and experience in negotiation and influencing others to change • Strong Business Acumen
NONE: No hazardous or significantly unpleasant conditions.
INTENT AND FUNCTION OF JOB DESCRIPTIONS
Influence, direct and lead multiple projects and cross functional teams to provide regulatory input on product development pathways and filing strategies for both US and global markets. Responsible for identifying thought leaders and outside consultants to help assist them in developing regulatory strategies for lifecycle products so that changes can be implemented quickly and correctly the first time. Must be able to work independently, represent the company business strategies and goals to outside customers and regulatory agencies. Must be able to support and manage other Regulatory Associates and provide regulatory guidance, support and understanding to our internal customers. Responsible for managing and coaching regulatory associates and SR regulatory associates. Provide cross functional training and understanding on regulatory requirements to sales and marketing, quality, operations, analytical development and product development. Communicate to senior management any policy and/or regulatory changes that will impact the business and develop regulatory strategies so that PDI and Nice-Pak can be proactive not reactive.
Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.
Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.