Regulatory Affairs Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. Essential Functions and Other Job Information: Essential Functions  Supports the preparation of documentation and submissions under guidance.  Coordinates and manages client deliverables supporting regulatory compliance.  Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting.  Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.  Assists in business development and pricing of projects for the department.  Evaluates client needs in relationship to overall project timelines, quality and delivery.  Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed. Job Complexity Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Job Knowledge Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Supervision Received Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action. Business Relationships Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters. Builds productive internal / external working relationships.

Qualifications: Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:  Good English language (written and oral) communication skills as well as local language where applicable  Good attention to detail and quality as well as editorial/proofreading skills  Good interpersonal skills to work effectively in a team environment  Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies  Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects  Good negotiation skills  Capable of working independently with direction and exercising independent judgment  Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables  Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management  Basic understanding of medical terminology, statistical concepts, and guidelines  Good analytical, investigative and problem-solving skills  Capable of interpreting data Management Role: No management responsibility

Working Conditions and Environment:

Work is performed in an office environment with exposure to electrical office equipment.  Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements:  Frequently stationary for 6-8 hours per day.  Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.  Frequent mobility required.  Occasional crouching, stooping, bending and twisting of upper body and neck.  Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.  Ability to access and use a variety of computer software developed both in-house and off-the-shelf.  Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.  Frequently interacts with others to obtain or relate information to diverse groups.  Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.  Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.  Regular and consistent attendance.