Hybrid working, with 50% onsite in Summit, NJ (can also consider candidates from Lawrenceville or New Brunswick)
Contract type: W2$70.00 per hour plus benefits
We have an exciting opportunity with a global biopharma company, with headquarters in New Jersey. G&L are working in partnership with this client to provide a number of experienced regulatory affairs professionals with expertise in small molecule CMC. We are looking for proactive, solutions-oriented talent with great communication skills to join this progressive team with an immediate start.
Responsibilities will include:
Participating in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.
Preparing and reviewing CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
Responsibility for the global regulatory evaluation of CMC change controls.
Providing project management and input to cross-functional teams, including CMC and Regulatory Affairs.
Developing and maintaining knowledge of regulatory environment, regulations and procedures.
Skills/Knowledge Required:
Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations)
Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
Experience in post-approval requirements
Experience in developing CMC regulatory strategy
Have an open, solution-oriented approach to problem solving
Ability to plan and prioritize work of group members and guide/develop others.
Ability to work on complex projects and within cross-functional teams
Excellent communication skills, strong English language skills
For further details, please send your CV to: talent@gandlhealth.com
G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race.
We recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity