Kelly Scientific is looking for a Pharmaceutical Regulatory Affairs Controller for a direct hire opportunity with one of our valued customers near Cleveland, Ohio
- manage and execute all electronic regulatory submissions to health authorities
- Exhibit strong leadership through BLA/MAA/WMA filings.
- Offers subject matter expertise in eCTD implementation through appropriate submission application installations in the following areas:
- electronic data management system eDMS
- publishing tools and publishing software
- regulatory project management.
- Manage and coordinate the planning, assembly, publishing, and submittal of regulatory submissions for the FDA and other regulatory agencies
- Manage regulatory projects and activities to meet submission timelines and document requirements
- Collaborate with multiple internal functional areas, external organizations, and other key stakeholders
- Provide leadership in global submission strategy
- guide regulatory staff and colleagues in implementation of these strategies
- submit successful regulatory filings up to, and including licensure applications
- Manage staff effectively to ensure milestones and service levels are met, including workload balance and day-to-day workflow
- Train Regulatory Operations support staff on eCTD guidelines and regulatory directives
- Oversee the development of the Regulatory Operations team,
- develop awareness of regulatory mindset among other employees
- Ensure development and/or control of regulatory required document management tools
- manage the implementation and ongoing enhancement of regulatory document compliance for electronic eCTD document management platforms and regulatory document control
- Develop and manage internal Standard Operating Procedures SOPs and processes
- work closely with IT and external vendors to ensure an updated and validated eCTD document management and regulatory document control platform
- Maintain up-to-date knowledge of guidelines and regulatory directives
- Perform QC on submission packages to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines.
- Bachelor s degree in a scientific, pharmacy or related discipline.
- Master s or PhD degree in a related field a plus
- Minimum of 8-10 years of Regulatory Operations experience, with at least 1 lead eCTD BLA or NDA successful filing
- In-depth knowledge of eCTD submission regulation/guidance
- Experience with MS Office, Adobe, eCTD publishing software systems, document management solutions, and publishing database software systems
- Proficiency in process and technology integration, with a focus on process improvement
- Strong skills in planning, organizing, decision-making and problem-solving
- Highly interactive interpersonal and management skills
- Extensive knowledge of eCTD publishing systems, EDMS technology, publishing tools, global submission standards, and industry trends for dossier preparation
- Experience in implementing principles of project management is a plus, and a proven ability to work under pressure and adhere to deadlines
- Creative out of the box thinker who can function autonomously with little supervision to establish a state-of-the-art regulatory operations functionality is a major plus.
Apply today or refer a friend!
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