Our client, one of the largest Healthcare companies in the U.S., is looking for a Regulatory Affairs Ops Specialist II which is Round Lake, IL. As a Regulatory Specialist you will be responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of client's products.
Job Title: Regulatory Affairs Ops Specialist II
Location: Round Lake, IL 60073
Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
•Initiate and develop complex regulatory project plans
•Identify & prioritize key areas of regulatory risk
•Monitor applicable regulatory requirements
•Create and maintain regulatory files in a format consistent with requirements
•Provide regulatory advice to project teams.
•Respond to complex questions from regulatory authorities within strict timelines
•Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
•Maintain and update existing regulatory authorizations
•Manage regulatory activities relating to specific portfolio of products/projects
•Prepare, review, and approve labeling and SOP's
•Lead or represent Regulatory Affairs in project teams
•Provide guidance and coaching for areas of responsibility to lower level team members
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
N/A: Intern or Co-op
•Knowledge of regulations
•Scientific knowledge
•Project management skills
•Manage multiple projects and deadlines
•Ability to multitask and prioritize
•Interpersonal and communication skills
•Strong negotiation skills
•Technical system skills (e.g. word processing, spreadsheets, databases, online research)
•Ability to work effectively in multinational/multicultural environment
•Ability to identify compliance risks and escalate when necessary
Education and/or Experience:
Include the education and/or experience that is necessary to perform the job satisfactorily.
0 N/A: Intern or Co-op
Bachelor's degree or country equivalent in a scientific discipline
Minimum of 5 years regulatory experience within a pharmaceutical company for medicinal products, CRO, or similar organization. FDA regulations and knowledge
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About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.