Hurley Consulting Associates, Ltd. is seeking a CMC Regulatory Affairs professional to join our Regulatory Affairs group. M.S. or advanced degree preferred with at least 15+ experience in areas such as R&D, CMC and Quality Assurance in the pharmaceutical industry.
The responsibility will include:
Prepare or review CMC technical documents, CTD Module 2, 3 and Module 3 for submissions.
Review of CTD Module 2.3 and Module 3 for technical content and compliance with regulatory requirements.
Participate in the development of global CMC regulatory strategies.
Manage novel compound contract manufacturing for drug substances and drug products
Knowledge of CMC, FDA, EMA and ICH guidelines.
Experience with IND preparation and IND amendments, NDA submissions and supplements and CTD format and electronic submissions.
Experience in management of multiple projects.
Analytical chemistry experience a plus.
RAC is a plus.
Hurley Consulting Associates Ltd. offers a competitive salary, health care benefits, group life insurance and 401(k) plan. Remote (optional).
Internal Number: 001
About Hurley Consulting Associates
Finding Solutions to your most difficult drug development challenges for over 30 years.
Hurley Consulting Associates Ltd. is an international consulting company serving the health sciences industry since 1987. With unique expertise to prepare datasets, reports, global regulatory submission documents and dossiers, Hurley Consulting integrates nonclinical, clinical, and manufacturing and control evaluations, performs data analyses, and develops and implements regulatory strategies.
For the last 30 years Hurley Consulting has supported clients for the entire IND through NDA process. We are recognized within the health sciences industry for the high level of our expertise and the excellent quality of our work.
Hurley Consulting offers clients a broad range of consulting expertise together with comprehensive contract research services and submission services including eCTD and CDISC. Our services range from nonclinical assessments, clinical trial design, data analysis, regulatory strategy and submissions, to marketing assessments.
We unite the strategy, planning, and analytical expertise needed for product development and for evaluation of business opportunities.
Come join our team.