Job Number: 21314244
- BS/BA degree in Scientific Discipline (Masters or higher preferred) with
5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
- Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations, and briefing documents).
- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations.
- Experience in drug development processes and post-approval requirements.
- Experience in developing CMC regulatory strategy.
- Experience in project management.
- Have a solution-oriented approach to problem solving.
- Ability to plan/prioritize work of group members and guide/develop others.
- Ability to work on complex projects and within cross-functional teams with supervision.
- Excellent communication skills, both written and oral.
- Change control (be able to work in CC systems i.E eQRMS, Infinity, Verity).
- Participate in the development of the CMC regulatory strategy for small molecules, biologics, and cell therapy submissions.
- These submissions include health authority briefing packages, IND/CTA, BLA/NDA, and MAA regulatory filings.
- Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
- Responsible for the global regulatory evaluation of CMC change controls with supervision.
- Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
- Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
- Participate in global regulatory interactions with health authorities, with supervision.
- Facilitate document review meetings and discussions.
- Develop and maintain knowledge of regulatory environment, regulations, and procedures.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jim: jim@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02301
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE