Title: Regulatory Affairs Director/Senior Director

　　Location: Allentown, PA

　　Schedule: 8am-5pm

　　Compensation: $160-200K

　　Type of hire: Direct

　　Overview:

　　Direct the activities of the Pharmaceutical Regulatory Affairs staff jointly with the Device RA Management staff related to obtaining product approval and maintaining global product marketing rights. Act as direct liaison and chief company contact with regulatory agencies, as well as with other internal functional departments for new product development and product life cycle strategy. Oversees existing products and obtains new marketing approval for new/modified drug and device applications globally. Act in a supervisory capacity for regulatory functions.

　　Responsibilities

　　Assists the SVP Medical Scientific Affairs & Chief Medical Officer and Corporate VP Regulatory Affairs in carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws.

　　Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance, rewarding and disciplining employees; addressing complaints and resolving problems.

　　Resident regulatory affairs authority for and primary regulatory contact for assigned product lines or projects.

　　Direct the activities of the Pharmaceutical Regulatory Affairs staff jointly with the Device RA Management staff related to obtaining product approval and maintaining global product marketing rights.

　　Act as direct liaison and chief company contact with regulatory agencies, as well as with other internal functional departments for new product development and product life cycle strategy.

　　Oversees existing products and obtains new marketing approval for new/modified drug and device applications globally. Act in a supervisory capacity for regulatory functions.

　　Requirements

　　10-15 years related experience, plus a minimum of 5 years management experience required.

　　Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.

　　Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees. Responsible for cost, method, and employee results.

　　Judgement is required in resolving complex problems based on experience.

　　Represents the organization as a prime contact on projects and departmental operations. Interacts with senior internal and external personnel on issues often requiring coordination across organizational lines.

　　Bachelor's degree required.

　　#M3

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.