Manager, Regulatory Affairs & CMC

Manager, Regulatory Affairs & CMC
Cambridge, MA

Molecular Insight Pharmaceuticals, Inc., located in Cambridge, MA, is a growing biopharmaceutical company specializing in the emerging field of molecular medicine, applying innovations in the identification and targeting of disease at the molecular level to improve patient healthcare by addressing significant unmet medical needs.

We are currently seeking a seasoned professional to liaise with project teams and obtain investigational new drug product information/data, as well as write sections of regulatory submissions to meet government requirements for the support of clinical studies of Investigational New Drug Products worldwide.

In this key role, you will:

• Write sections and manage the compilation of regulatory submissions required to support clinical studies as Product Development progresses. Studies include: IND Annual Reports, CMC Amendments, New Investigator Information, and Pharm/Tox Reports for FDA and International Regulatory Authorities, etc.
• Provide status on regulatory submissions/correspondence with regulatory authorities, and respond to questions regarding regulatory issues
• Review QA and Clinical and Pharm/Tox documents and reports for compliance with U.S. and International government regulations
• Write/review SOPs and train staff
• Assist with the preparation of electronic submissions

This position requires:

• A BS in Analytical Chemistry, Chemistry or Biochemistry
• 2+ years of lab experience in the Pharmaceutical industry (such as bench chemist experience, analytical chemistry experience, QC/QA experience, pharmaceutical production, etc.).
• 3-5+ years of regulatory affairs experience in preparing all types of regulatory submissions (including IND Amendments, CMC, Clinical, Pharm/Tox and IND Annual Reports to FDA and internationally)
• Hands-on experience reviewing and critiquing documents received from other members of the project team (such as Stability Reports, batch records and analytical test methods) to ensure they meet cGMP regulatory requirements
• A solid understanding of U.S., Canadian and ICH regulations 21CFR312 regarding investigational new drugs, clinical studies and IND requirements, as well as the New Drug Application process (21CFR314)
• Experience with eCTD submissions format
• Success writing, reviewing and coordinating the approval of SOPs with members of other departments
• PC proficiency with MS Word & Excel and software used for regulatory submissions preparation
• Previous experience with radiopharmaceutical drug products preferred

Molecular Insight Pharmaceuticals offers competitive compensation & benefits. If you thrive in an entrepreneurial, stimulating environment where initiative and individual contributions are valued, recognized and rewarded, we’d like to hear from you.

Please email your resume and three references to: careers@molecularinsight.com

No phone calls please.

Equal Opportunity/Affirmative Action Employer M/F/D/V.

www.molecularinsight.com