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Global Regulatory Manager, IPS – Sealing, Lidding, Tubing
TekniPlex. Manage the maintenance of the Consumer Products Rapid Regulatory Response System (RRRS), ensuring raw materials used on the CPD plant locations are captured, that the regulatory information is current, and provide support to various teams regarding raw materials that are found to have compliance concerns.
About the role
Key responsibilities & impact- Manage the maintenance of the Consumer Products Rapid Regulatory Response System (RRRS), ensuring raw materials used on the CPD plant locations are captured, that the regulatory information is current, and provide support to various teams regarding raw materials that are found to have compliance concerns.
- Issue Drug Master File (DMF) Letters of Authorization (LOAs); amend DMFs; and complete FDA annual reports for DMFs
- Provide support to Quality and Procurement during SQF Audits; maintain regulatory documentation on an annual basis for multiple plant locations.
- Provide timely response to varied customer requests submitted by Quality, Customer Service, Sales, or Others, including FDA statements, EU 10/2011, CONEG, RoHS, TSE/BSE/Animal Origin, Allergens, REACH (SVHC), California Proposition 65, BHT, Bisphenols, Phthalates, PFAS/PFOA/PFOS, Conflict Minerals, MOSH/MOAH, Nitrocellulose/Nitrosamines, others.
- Responsible for providing input and technical expertise to internal Regulatory, R&D and Procurement.
- Support the ENHESA or any other specialized software activities for the Consumer Products Division.
- Actively support the Global Regulatory Director in customer requests, both internal and external.
- Work cross functionally with wider business team to ensure all company business objectives are met/exceeded
- Coordinates with functional teams to implement effective collaboration and knowledge management measures.
- Participate on various NPD teams to ensure they have appropriate regulatory information for all key development programs.
- Actively participate in global regulatory community efforts. Evaluate best practices learned from internal or external sources. Participate in information sharing activities as important regulatory concerns arise; generate slide decks and present regulatory information to internal and external customers.
Requirements
What you’ll need- Bachelor’s Degree in an applicable area such as regulatory, quality, engineering or a technical discipline
- Five (5) or more years of overall relevant experience with three (3) or more years in a regulatory capacity in the food, pharmaceutical or similar industry
- Detail oriented, organized and able to manage multiple tasks and projects
- Knowledge and experience with applicable regulations (FDA statements, EU 10/2011, CONEG, RoHS, TSE/BSE/Animal Origin, Allergens, REACH (SVHC), California Proposition 65, BHT, Bisphenols, Phthalates, PFAS/PFOA/PFOS, Conflict Minerals, MOSH/MOAH, Nitrocellulose/Nitrosamines)
- Has held customer-facing roles within the Regulatory function
- Demonstrated success supporting compliance audits
- Ability to communicate at all levels of the organization, and other third parties. Ability to establish credibility, trust and strong working relationships both inside and outside the company.
Benefits
Comp & perks- Medical, Dental, and Vision
- Life and Disability
- 401(k) and Match
- Wellness Program including EAP
- Pay for Performance philosophy
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
Drug Master File (DMF)FDA annual reportsregulatory documentationSQF Auditsregulatory complianceENHESAregulatory information managementNPD (New Product Development)best practices evaluationslide deck presentation
Soft Skills
detail orientedorganizedproject managementcustomer-facingcommunicationcredibilitytrust buildingrelationship managementcollaborationknowledge management
Certifications
Bachelor’s Degree in regulatory, quality, engineering or technical discipline