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 products. • Knowledge of Medical Devices preferred • 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 Industry experience. • Management/supervisor experience preferred. • 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
Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.
All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.
In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.
Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
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.
Internal Number: 18-0033
About PDI Inc
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.