Regulatory Affairs Manager/Senior Manager - Global Regulatory Affairs Strategy - Home or Office Based Anywhere in the US or Canada
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 9+ 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:
- Excellent English language (written and oral) communication skills as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Excellent negotiation skills
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
- Superb understanding of medical terminology, statistical concepts, and guidelines
- Excellent analytical, investigative and problem-solving skills
- Excellent understanding of budgeting and forecasting
- 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.