Biotechnology, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
G&L are working in partnership with a leading international biopharmaceutical organisation who have an incredible pipeline of new products. We have an exciting opportunity for someone with true project management skills to lead their global programs, and be at the cutting edge of regulatory development.
We are looking for a true Regulatory Affairs program manager to join our US team, who will be based at our site in Warren, NJ or alternatively on-site with our client in northern New Jersey.
Role Description: Regulatory Strategist – northern New Jersey
Being a US regulatory subject matter expert and FDA liaison for assigned development projects
Developing and executing US regulatory strategies for the development of new and existing pharmaceutical and biologics products
Planning, coordinating, and preparing IND, NDA, and BLA submissions
Leading and providing regulatory input to cross-functional project teams
Coordinating FDA meeting preparation (briefing books, rehearsals, response to FDA questions) and participating in FDA meetings
Interpreting new or existing regulatory requirements relevant to assigned products and projects
A minimum of a Science-based BS or MS
A proven career history with relevant experience in US regulatory and drug/biologic product development in Phases I-IV
Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry
Experience working with Oncology, Immunology, Neurology product portfolios would be an advantage
CAR-T cell, and gene therapy experience would be an advantage
Strong interpersonal skills, communication, and negotiation skills
A qualification in Project Management or proven track record of leading large projects
Your daily workload will be fluid and completely responsive to our clients’ requests – and no project is the same. We need someone who is an excellent communicator, a selfless team player, a brilliant multitasker – but most of all, someone who has a good sense of humour! We want to enjoy our work, have a happy office and consistently deliver exceptional services to our customers – so we are only recruiting people with a can-do, why-not, positive attitude. We are looking for new team members who are flexible to work at our locations, or attend meetings or projects at our clients’ sites in New Jersey area, and who can start Q1 2019.
If you would be interested in joining the team at G&L Scientific, please send your CV to email@example.com today.
G&L Scientific 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.
Internal Number: 1111
About G&L Scientific Inc
G&L Scientific provides consulting, staff augmentation, outsourcing and support services for Clinical Research and Regulatory Affairs. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of more than 2,500 global consultants, the key to G&L’s success is a straightforward, transparent approach; experience of unrivalled depth; and the recruitment and development of brilliant people. Indeed, the level of repeat business and ongoing long-term assignments is testament to the quality of service G&L provides.
Whether our client needs an individual RA professional or full project team, onsite or remote, G&L will design a custom solution that delivers significant savings and flexibility in line with operational demands.
As well as excellence in our chosen fields, we are renowned for the quality of our people. Our real success lies in recruiting and developing brilliant consultants. We seek the right individuals to match our business needs, then build the environment that allows them to fulfill their potential. People join G&L Scientific for a variety of reasons. Some want to work with the very latest developments in Clinical Res...earch & Regulatory Affairs, others want the opportunity to make a real difference working in a dynamic and pioneering team. Ultimately, G&L people are free-thinking, proactive and creative individuals who are not afraid of change.