The primary purpose of this position is to provide Quality Project Management support and leadership to ensure accurate and timely submissions and responses to regulatory agencies for new and transferred products. This individual is expected to apply their technical knowledge and communication skills to facilitate collaboration across multiple departments within multiple sites. This individual will also review and evaluate scientific, analytical and technical data as it pertains to product testing and manufacture in support of regulatory submissions. This person should be able to work independently and in groups to identify and solve complex problems.
- Develop, organize and manage document tracking for the facilitation of Regulatory submissions/responses.
- Lead cross-functional meetings and discussions for the timely collection of documents for Regulatory submissions/responses.
- Evaluate, review and approve relevant submission documents.
- Identify problems and provide technical/analytical/scientific leadership for problem resolution.
- Promote collaboration and communication between multiple departments within multiple sites.
- Maintain awareness of requirements for USP, FDA, ICH, WHO and other international agencies.
- Hands on participant in all stages of product lifecycle.
- Act as central Quality contact between Head Office and Site.
- Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
- Maintain knowledge of current regulatory requirements and standards as they pertain to documents required for submissions.
- Represent company as appropriate in FDA, notified body, internal and other regulatory audits.
- Identify areas for improvement and provide leadership for solutions.
- Develop, facilitate or request required documents and provide to key stakeholders in organized manner.
- Evaluate and continuously improve systems, quality and compliance with regulatory requirements, best practices and quality systems procedures.
- Be proactive with regulatory and industry changes.
KNOWLEDGE, SKILLS, AND ABILITIES:
- A minimum of a Bachelor’s degree in Science or Engineering or associated field is required.
- A minimum of 2 years or more of experience in a Pharmaceutical environment, including experience with regulatory audits.
- Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), USP and ICH guidelines.
- Strong documentation skills are required, including writing SOPs, technical papers and investigations.
- Proficiency with Microsoft Word, Microsoft Excel and Power Point are required. Excellent typing skills are required.
- Strong organizational and communicative skills are imperative.
- The ability to work independently and within a team structure and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must be a technical expert and have excellent written and oral communication as well as interpersonal relationship skills.