What are the responsibilities and job description for the Regulatory Affairs Associate position at Actalent?
Responsibilities:
Provides regulatory support and guidance
associated with US market actions, including analysis of the requirements and
tracking of deliverables. With minimal oversight from manager, supports
execution of US market actions regulatory strategies for approved market action
decisions including product removals, customer notification and regulatory
correspondence and assists in creation and maintenance of market action files,
records, and database. Assures full regulatory compliance of all documentation
for market action strategy.
Knowledge & Skills
• Review critical documents, seeking guidance when necessary, and determine acceptability for regulatory submission.
• Identify documentation deficiencies and work with colleagues to accomplish resolution.
• Apply good judgement and decision making in day to day project issues as they arise.
• Engage others to support resolution of issues with minimal oversight.
• Understand US FDA regulations, specifically 21 CFR Parts 7 and 806, and assures regulatory compliance.
• Prepare and maintain regulatory strategy, with minimal oversight.
• Exercise good judgment within policy and regulations.
• Detail oriented, accountable for accuracy and quality in work and meeting multiple, simultaneous deadlines.
• Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of
regulatory management.
• Presents scientific data effectively orally and in writing in a logical and persuasive manner, with minimal
oversight.
• Effectively manages own workload and appropriately prioritizes to meet business and compliance requirements.
• Negotiate with other areas to ensure compliance with standard processes.
• Acts with minimal oversight on routine issues, makes judgment and executes in alignment with regulatory management.
Qualifications:
• Bachelor’s Degree from an accredited college/university, required, preferably in pharmacy, biology, chemistry, pharmacology, engineering, or related subject.
• Minimum of 2 years of experience in the medical products industry or relevant medical device/drug experience.
• Minimum of 2 years of experience in Quality Assurance, Regulatory Affairs, Compliance, Research, Development or
related area.
• Proficient with computer and standard software programs, with excellent word processing, presentation and spreadsheet application skills and the ability to learn new computer interface systems.
• Able to assess scientific arguments and apply analytical and logical reasonings.
• Ability to effectively prioritize workload and multitask with minimal supervision.
• Good interpersonal and communication (written and oral) skills.
• Demonstrated project management skills.
• Demonstrated critical thinking, contingency planning and negotiating skills.
• Understanding of regulatory and business needs with ability to engage cross functional team members.
Work Environment
• This job operates in a professional office
environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of
the time.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Salary : $30 - $36
