Sr. Regulatory Submissions Executive
Proclinical is currently recruiting for a Senior Regulatory Submissions Executive for a pharmaceutical company located in Durham, NC. Successful candidate will be responsible for assuring the quality of clinical development systems, processes and related activities in the USA.
- Service providers (CROs, suppliers)
- Internal audits (activities, processes and systems)
- External and study specific audit plans
- Conduct audits of Investigational sites and Service Providers for qualification routine surveillance or for cause purposes as well as Internal Audits (systems, processes, tools) and independent reviews of documents.
- Act as a Clinical QA representative for the activities initiated by the three Strategic & Innovation Groups and liaise with Operational Partners to have an in-depth knowledge of the clinical programs and studies, of their rationale.
- Inform, as GCP Subject Matter Expert, operational partners and Quality management of any issue adversely or potentially impacting quality, compliance or safety; recommend appropriate corrective actions,
- Participate to the preparation of trends analyses and recommend corrective actions.
- Conduct or contribute to periodic GCP Quality reviews and to the preparation of the annual Management review.
- Lead/support continuous improvement activities and conduct internal training on Quality standards and regulations.
- Perform Quality Documents Review (e. g SOPs, instructions).
- Perform internal training on Quality standards and regulations.
- Host GCP regulatory inspections in North America.
- Support the Innovation Quality Management regarding reporting tasks, definition and respect of the budget.
- Manage and develop directly reporting staff.
- Other duties as assigned. Qualifications
Skills and Responsibilities:
- Seven or more years of industry (Pharmacy, Chemistry, Cosmetics, Food Processing, Medical Devices) experience and solid experience in Clinical Quality auditing.
- Experience of internal and external audits in an international environment.
- Familiar with procedures and the ability to apply/implement them correctly in appropriate circumstances.
- Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice.
- Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts.
- Strong analytical, project management skills.
- Strong knowledge of MS Office (Excel, Power Point).
- Experience with eDocument Management, Training, CAPA's, Audit systems and tools. Education Requirements Bachelor's degree from a four-year college or university is required; degree in life sciences discipline strongly desired; advanced degree preferred
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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