21 Regulatory Affairs Specialist II - Hybrid Jobs in Round Lake, IL
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Regulatory Affairs Specialist II - Hybrid
$79k-102k (estimate)
Full Time
1 Week Ago
Primary Talent Partners is Hiring a Regulatory Affairs Specialist II - Hybrid Near Round Lake, IL
Primary Talent Partners has a hybrid 6 month contract Regulatory Affairs Specialist opening with one of our Healthcare/Life Sciences clients located in Round Lake, IL. Pay is $36 to $41 per hour based on overall experience. Please note: You will be sitting on a W2 Contract with Primary Talent Partners at an hourly basis without PTO/Benefits — We cannot provide or transfer Visa sponsorship, and we are unable to accept C2C, F1 or STEM OPT, or 1099 candidates. Summary: The Regulatory Affairs Specialist is responsible for executing complex global regulatory strategies to secure and maintain marketing authorizations for our products. This role supports the communication of regulatory requirements critical to product licensing. Serving as a consultant to managers, the Specialist manages regulatory activities across a specific global portfolio of products and projects.
Essential Duties And Responsibilities
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com#PTPJobs
Essential Duties And Responsibilities
- Initiate and develop comprehensive regulatory project plans to guide strategic implementation.
- Identify and prioritize key areas of regulatory risk, ensuring proactive mitigation strategies.
- Monitor and interpret relevant regulatory requirements, maintaining awareness of updates and changes.
- Establish and maintain regulatory files in compliance with applicable standards and guidelines.
- Provide expert regulatory advice to project teams, guiding decision-making processes.
- Respond to complex inquiries from regulatory authorities within specified timelines.
- Compile, review, and submit regulatory documents accurately and on schedule.
- Manage ongoing maintenance and updates to existing regulatory authorizations.
- Oversee regulatory activities specific to assigned portfolio of products/projects.
- Review and approve labeling and Standard Operating Procedures (SOPs) in compliance with regulatory standards.
- Act as a leader or representative of Regulatory Affairs within cross-functional project teams.
- Provide mentorship and guidance to junior team members within the regulatory function.
- Comprehensive knowledge of global regulatory requirements and guidelines.
- Strong scientific background, ideally with a Bachelor’s degree in a scientific discipline or equivalent.
- Proven project management skills, capable of managing multiple projects and deadlines effectively.
- Ability to multitask and prioritize tasks based on business needs and regulatory timelines.
- Excellent interpersonal and communication skills, with the ability to influence and negotiate effectively.
- Proficiency in technical systems such as word processing, spreadsheets, databases, and online research tools.
- Experience working in a multinational or multicultural environment.
- Ability to identify compliance risks and escalate issues when necessary.
- Bachelor’s degree in a scientific discipline or country equivalent.
- Minimum of 5 years of regulatory experience within a pharmaceutical company, CRO, or similar organization.
- Strong understanding of FDA regulations and regulatory affairs practices related to medicinal products.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com#PTPJobs
Job Summary
JOB TYPE
Full Time
SALARY
$79k-102k (estimate)
POST DATE
06/17/2024
EXPIRATION DATE
07/13/2024
WEBSITE
primarytalentpartners.com
HEADQUARTERS
Charlotte, NC
SIZE
<25
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