Description
A leader in pharmaceuticals and medical devices, located in Illinois, is in need of a Regulatory Affairs Product Manager. The company specializes in generic injectables and infusion pumps.The Regulatory Affairs Product Manager will have the following responsibilities:
- Develops regulatory strategies for development projects and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities.
- Manages the preparation of registration packages and responses to deficiency letters. Negotiates submission data requirements and deliverable dates with regulatory authorities and internal technical teams. Author with team members, key pieces of regulatory submissions.
- Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.
- Evaluates manufacturing and labeling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
- Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.
- For managers with people management responsibilities, provide managerial support and training to employees by supervising staff, establishing employee goals that align with other business partners, maintaining job descriptions, creating employee development plans, providing performance feedback and recruiting and retaining staff members.
The Regulatory Affairs Product Manager must meet the following requirements:
- B.S in pharmacy, biology, chemistry, engineering or a related field (Masters preferred)
- Five to eight years experience in the pharmaceutical industry or relevant medical device experience as needed for the position.
- Minimum of three years experience in regulatory affairs, research and development or quality assurance/compliance.
- Two years of direct people management experience preferred (for positions with people management responsibilities).
- Experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency guidances and regulations.
- Able to challenge scientific arguments.
- Excellent oral and written communication skills.
- Good interpersonal skills.
- Good negotiating skills.
- Good understanding of business needs.
This is a 12 month contract with the potential to go full time. The rate is $40-$55/hour.
To find out more about Real please visit www.realstaffing.com