Director Regulatory Affairs Regulatory Policy amp Intelligence

Profile

Director, Regulatory Affairs Regulatory Policy & Intelligence

The candidate utilizes knowledge of the scientific, regulatory , and business environment regarding how medicinal products (and medical devices where appropriate) are developed, evaluated, authorized and monitored once marketed to support product development strategy.. Develops and maintains strong partnership with regional area and affiliate staff that interact with Health Authorities (HAs). Monitors external environment for evolving policies that impact product development and works closely with Subject Matter Experts (SMEs) to analyze impact and plan strategy accordingly. Supports development and maintenance of relations with HAs, peer company and industry trade associations regarding scientific and regulatory policies. Co-ordinates cross-functional, multidisciplinary teams, to comment to HAs. Through knowledge gained, assists company to comply with scientific, ethical, statutory, quality, and business requirements. Independently manages regional topics in the regulatory policy and intelligence function. Supports definition of scientific and regulatory policy initiatives. May serve as policy subject expert based on in depth knowledge of key regulatory and scientific issues. Analyzes proposed policies and distributes to SMEs. Supports development of formation of corporate position to share with trade associations. Prepares complex written and oral reports for Senior Management and external audiences on scientific and regulatory topics. Proposes sound regulatory policies influencing the regulatory environment in one or more geographic regions. Effectively uses negotiation skills to resolve policy issues when unable to agree internally. Anticipates consequences of path chosen. Serves as liaison to trade associations for management of scientific and regulatory issues. Supports supervisor and Senior Management in discussions of complex policy topics at trade associations. Contributes to regulatory product development strategy by responding to information requests and providing an analysis of the regulatory environment. May offer alternative views based on regulatory knowledge and prior experience. Conducts external outreach with regulators, peers and trades. Responds to opportunities to enhance relationship by participating in policy-related meetings. Utilizes local network of pharma companies to obtain policy-related information.

Additional Information

Ref: 2004332

Company info

AbbVie Inc.
1 N Waukegan Rd
North Chicago
Illinois
United States 60064
Website : http://www.abbvie.com