Regulatory Affairs Specialist
Holland, MI US
Job Description
Regulatory Affairs Specialist
Global industry leader is looking for a Regulatory Specialist as their business continues to grow organically and through acquisitions.
Responsibilities:
The Regulatory Affairs Specialist will be responsible for day-to-day Regulatory Affairs activities including document change request reviews and approvals, regulatory agency submissions such as annual reports, Letters of Authorization, and Drug Master File amendments, in addition to responses to product specific customer inquiries. Duties include:
- Prepares global regulatory documentation and registration in support of customers, and company’s strategic business objectives; including but not limited to Drug Master Files, Annual Reports, and Supplements
- Approves all Change Requests, Variations, etc. for compliance to filed DMF parameters. Prepares responses to Customers. Prepares and approves global label copy
- Prepares responses to regulatory agencies; including but not limited to Deficiency Letters, Establishment Registration, and Product Registrations
- Coordinates development of information necessary to complete filings with Analytical Services, Engineering, Manufacturing, Quality Control, Quality Assurance, and Research and Development
- Coordinates validation of all aspects of company operations, facilitates and processes for compliance to GMP, SOP and company requirements
- Participates in inspections of company by regulatory agencies. Coordinates the company Record Retention Policy for QA and Regulatory Documents
- Prepares reports and recommendations to management based on review and analysis of regulatory enforcement trends
**If you’d like to hear more about this opportunity and others we are currently working on, please contact Crystal Meeks at cmeeks@cps4jobs.com.
JO: 16.23CM
#LI-CM1
Job Requirements
Required Qualifications:
- Minimum 2 years’ experience and Associate’s degree
- Minimum 1 year experience and Bachelor’s degree
- Experience in Quality Assurance
- Ability to work and collaborate with other departments including engineering, operations and research and development
- Good computer skills, critical thinking skills, attention to details and good communication skills are required
- Understanding of FDA regulations and guidance documents applicable to pharmaceutical manufacturing
Preferred Qualifications:
- eCTD experience
- Past experience in a FDA regulated manufacturing environment
- Master Control experience is a plus
**If you’d like to hear more about this opportunity and others we are currently working on, please contact Crystal Meeks at cmeeks@cps4jobs.com.
JO: 16.23CM
#LI-CM1
Meet Your Recruiter
Crystal Meeks
Sr. Technical Recruiter Environmental Health and Safety
My team recruits for all levels of EHS/Regulatory roles from specialists/engineers to directors/vice presidents. We place EHS professionals in single site, regional, and corporate positions. Examples of the specialty roles we recruit for include, but are not limited to:
• Environmental
• Environmental, Health, and Safety
• Industrial Hygiene
• Management of Change
• Occupational Nurse
• Process Safety Management
• Product Stewardship
• Regulatory
• Risk Management
• Safety
• Security
Industries we serve include, but are not limited to:
• Chemicals
• Construction
• Consumer Products
• Food & Beverage
• General Manufacturing
• Inks and Adhesives
• Medical Devices
• Packaging
• Paints & Coatings
• Petrochemical
• Pharmaceutical
• Plastics
• Polymers
• Refining
If you have interest in finding an opportunity that aligns with your career goals, or if you are a hiring manager looking for talent that can add value to your organization, I would love to hear from you! CMeeks@cps4jobs.com 312.668.8985
My recruitment philosophy encompasses the belief that people are the greatest asset in an organization. Finding the right fit is not only about the technical capabilities. It is about how an employee fits within an organization's culture and ensuring that both parties can add value immediately and in the future.