Job Description

Job Title: RA Sr Specialist - US drugs Duration: 12 Months (It might be extended after this for another year). Location: Deerfield, IL Hybrid preferred Onsite/Remote: on site (preferable) Payrate - $68/hr - $70/hr on W2 Interview process: (Teams/Onsite, Length, Rounds, Team involved)- Teams Top 3-5 Must-Have Non-Negotiable Skills Required

1. US/FDA drugs experience and regulation knowledge
2. Clear Communication skills
3. Global environment experience
4. Work autonomously
5. Ability to multitask and prioritize

Is a bachelor's degree required? Yes How many years of recent experience does this person need to have? Minimum 3 Essential Duties and Responsibilities. This section contains a list of primary responsibilities of the work. The incumbent will perform other duties as assigned.

• With direction, develop and execute regulatory project plans
• Identify and elevate key areas of regulatory risk
• Maintain regulatory files in a format consistent with requirements and perform MoH submissions
• Maintain awareness of regulatory requirements; identify relevant requirements
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to 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
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling and SOP's
• Represent or lead Regulatory Affairs in small project teams

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
• Negotiation skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• 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 Education: Bachelor's degree or country equivalent in a scientific discipline Minimum of 3 years regulatory experience in drugs within a pharmaceutical company, CRO, or similar organization. Experience in US/FDA regulations and submissions is required; experience in EU and/ or Rest of the world will be a plus. eTeam

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