Regulatory Expert for Pharmaceutical and Medical Device Quality
4 days ago
Company Overview
Excellis Health Solutions, LLC is a global strategic management consulting services firm with a strong presence in the United States, Europe, and other regions. As a leading industry player in supply chain management, we cater to pharmaceuticals and life sciences companies, providing comprehensive solutions using our extensive knowledge and proven turnkey solutions.
Salary: $120,000 - $180,000 per annum
Job Description
This senior regulatory position will be responsible for delivering quality expertise to both internal teams and external clients. The incumbent will need to stay up-to-date with current regulations, interpret proposed regulations, and provide expert input on regulatory compliance matters. This role will also involve overseeing the associated quality compliance aspects of regulations as they pertain to client operations.
- Understanding and interpreting FDA regulations for pharmaceutical and medical device products, including those related to product development, manufacturing, labeling, packaging, testing, storage, and distribution.
- Interpreting DSCSA regulations for pharmaceutical prescription products across the entire supply chain (manufacturer to consumer).
- Understanding cGMP quality compliance aspects derived from relevant FDA regulations.
- Conducting internal and external audits to evaluate quality compliance and conformance to regulatory requirements and organizational QMS.
- Developing and recommending CAPA activities.
- Evaluating the adequacy of QA procedures and policies.
- Supporting the implementation of QMS.
- Monitoring risk management activities.
- Collaborating with project teams to ensure compliance requirements are understood and addressed in project deliverables.
- Staying current with industry regulations and quality compliance trends.
Qualifications and Education Requirements
- Prior experience in pharmaceutical and medical device regulatory affairs within the FDA-regulated industry.
- Experience with DSCSA regulations for prescription pharmaceutical products.
- Knowledge of Product Launch regulations.
- Prior quality compliance experience within the FDA-regulated industry, including conducting audits.
- Prior consulting experience.
- A self-starter with the ability to work independently on a project-by-project basis.
- A BS degree or higher in a relevant field.
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