USA - Regulatory Affairs Ops Specialist II- Kronos Job at eTeam, Inc., Round Lake, IL

cXV3aDQ3VUIwNzhiQUJNb1ZGWG9rdkJ5N2c9PQ==
  • eTeam, Inc.
  • Round Lake, IL

Job Description

Title: Regulatory Affairs Ops Specialist II
Location: Round Lake, IL (Hybrid)
Duration: 6 Months
Pay Range: $35.00 to $40.00/hr on W2

Summary:
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. Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products/projects.

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.
0 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

Job Tags

Internship,

Similar Jobs

JBS

SANITATION 3RD SHIFT Job at JBS

DescriptionPosition at Pilgrim'sSanitationWorkerKeyResponsibilitiesandAccountabilitiesincludebutarenotlimitedto:CleaningandsanitizingproductionareasCompletemandatorysafety trainingasoutlinedfortheJobassignmentCompletemandatoryfoodsafety/GMPtrainingasouthnedfortheJ...

Abaci Consulting, Inc.

Landscape Architect Job at Abaci Consulting, Inc.

 ...LANDSCAPE ARCHITECT Abaci Consulting, Inc. is seeking a full-time licensed Landscape Architect to join our team in Grimes, Iowa. This position will serve as a leader for technicians and team members in the preparation of land development plans, reports, and proposals... 

GDIT

Admin Assistant III - TS/SCI w/Polygraph Job at GDIT

 ...Candidate must be able to operate in a team environment as well as successfully work on their own This position is on customer site GDIT IS YOUR PLACE: ~401K with company match ~ Comprehensive health and wellness packages ~ Internal mobility team dedicated to... 

Best Days Travel

Work From Home- Hotel Reservations Agent- No Experience Needed Job at Best Days Travel

 ...Work From Home Hotel Reservations Agent (No Experience Needed!) Entry-Level | 1099 Independent Contractor | Flexible Schedule Do you love travel and want to help others plan their perfect staysall while working from home? As a Hotel Reservations Agent , youll... 

Windsor Fashions

Copywriter Job at Windsor Fashions

 ...Knowledgeable about fashion and passionate about current and upcoming fashion trends; able to translate trends into compelling copy that speaks to women 1825 years old Experience working on rebranding campaigns desired but not required Experience using Google Drive,...