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Regulatory Affairs Ops Specialist II
25212 W IL Route 120 Hainesville, IL 60073 US
Job Description
Target Pay Rate: 35-38.87/hr **salary will be commensurate with experience
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 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 SOPs
- 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
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- 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:
Bachelors 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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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