Cameron Craig Group
Director - Regulatory Affairs
Cameron Craig Group, Branchburg Township, New Jersey, United States,
Lead regulatory strategy and submissions.Collaborate with R&D, Technical Ops, Clin Dev, etc. to advance the company’s drug portfolio in order to ensure commercial success.Responsibilities:
Guide development programs to meet both US and global regulatory standards.Provide strategic regulatory direction from product concept through market launch.Shape new regulatory pathways in order to benefit stakeholders.Requirements:
7–12 years of regulatory experience in the pharmaceutical/biopharmaceutical industry.Proven track record in regulatory leadership, including 505(b)(1), 505(b)(2), 505(j), etc.Experience in filing and obtaining FDA and international approvals.Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases.Experience working with FDA and other regulatory bodies.Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.
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Guide development programs to meet both US and global regulatory standards.Provide strategic regulatory direction from product concept through market launch.Shape new regulatory pathways in order to benefit stakeholders.Requirements:
7–12 years of regulatory experience in the pharmaceutical/biopharmaceutical industry.Proven track record in regulatory leadership, including 505(b)(1), 505(b)(2), 505(j), etc.Experience in filing and obtaining FDA and international approvals.Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases.Experience working with FDA and other regulatory bodies.Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.
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