Regulatory Affairs Manager

A leading scientific organization is seeking to recruit a Regulatory Affairs Manager to their office in Pennsylvania. The company designs and conducts biomarker-driven cancer research involving audits who have or are at risk of developing cancer. Based in Philadelphia, this role is an exciting opportunity to provide expertise and leadership in the regulatory field.

Job Responsibilities:

• Understanding all the requirements and mechanics related to the Investigational New Drug Application process.
• Interacting regularly with officials and representatives from the FDA and NCI.
• Maintaining clinical trial regulatory submissions and assisting with the submission and acceptance of these submissions.
• Assessing clinical trial drug packages in pharmaceutical and clinical settings.
• Preparing, reviewing, and approving clinical trial regulatory documents.
• Ensuring regulatory compliance with clinical trial agreements and related documents.
• Providing clinical trial regulatory input on an as-needed basis.
• Providing clinical trial regulatory viewpoints and expertise to teams.
• Reviewing clinical trial protocols and clinical trial plans and ensuring alignment with regulatory requirements.
• Ensuring clinical trial quality management, sourcing, and supply regulatory adherence is achieved and maintained in all related clinical trial processes.
• Supporting line managers with creating, implementing, and developing clinical trial regulatory strategies.
• Proposing process improvements and assisting and following through in implementation.
• Reviewing and creating standard operating procedures (SOPs).
• Performing regulatory trainings for management and staff
• Responsible for ad hoc projects as determined by the Vice President of Operations.

Skills and Requirements:

• Master's degree in a related discipline from an accredited college or university, though a Pharm.D. or Ph.D. degree is strongly preferred.
• Relevant professional experience is required.
• Master's degree in a related discipline from an accredited college or university and relevant professional experience is required.
• D. or Ph.D. degree is strongly preferred.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

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 contact Mary Jacobs at +267-477-4800 or upload your CV 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.

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