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.
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.
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.
1. Project management
2. Regulatory Compliance
3. Number of Regulatory Submissions
4. Number of Regulatory Approvals
5. New Product Launches
6. Team Development