Department: Regulatory Affairs
Job Title: Regulatory Affairs CMC Senior Associate
Description:
Assists in planning, review and preparation of CMC (chemistry, manufacturing and control) components of regulatory submissions to support clinical trials and product registration. Provides advice on CMC strategies and solutions to ensure compliance with regulatory authority regulations and interpretations. Participates on development teams to represent the functional area. Reports to the Manager CMC Regulatory Affairs.
Duties and Responsibilities:
- Assist in the preparation, review and submission of investigational new drug applications (INDs), IND amendments, and corresponding foreign submissions that are complete, properly formatted and in compliance with applicable regulations.
- Assist with development of effective regulatory strategies for global product development, and recommend such strategies to development team members and/or supervisor, as appropriate.
- Interact with regulatory personnel (FDA, EMEA, HPFB, etc.) as appropriate.
- Review documentation from departments outside Regulatory Affairs. Provide advice as to regulatory acceptability of plans for drug development, CMC, or labeling through individual as well as development team contacts.
- Prepare interpretive analyses of key regulatory guidance documents, regulations, or directives that impact ARIAD's products and operations.
- Contribute to the development of project plans leading to drug product approval.
Job Requirements:
Position requires a minimum of a B.S. in chemistry or a related field, with excellent written communication skills. Must have a working knowledge of the drug development process in general, and CMC regulatory requirements and guidances in particular. At least 5 years of pharmaceutical industry experience, including a minimum of 2 years of prior regulatory experience preferred. Prior NDA submission experience a plus.
