REGULATORY AFFAIRS PROFESSIONALS: Program Lead, Director
G&L Scientific Inc
May 1, 2018
San Francisco, California
Full Time - Experienced
Biotechnology, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
Our excellent reputation within the pharma industry has been built on smart, tailored solutions for each of our clients, ensuring that their expectations are surpassed, and all their requirements are exceeded. Our people are the ones who deliver this exceptional service – we are looking for the best talent to join our team and develop as our company expands.
We are currently looking for senior professionals to join our core team of employees – we have nationwide opportunities, with a focus on the San Francisco bay area.
Your role may include some of the following duties, but this is not a definitive list; each project is different – so a broad skills portfolio and flexible approach is invaluable.
Being a US regulatory subject matter expert and an FDA liaison for development projects: developing and executing US regulatory strategies for the development of new and existing pharmaceutical and biologics products; Interpreting new or existing regulatory requirements relevant to products and projects.
Planning, coordinating, and preparing IND, NDA, and BLA submissions; leading and providing regulatory input to cross-functional project teams; coordinating preparation for FDA meetings (Briefing books, rehearsals, response to FDA questions) and participating in FDA meetings
Being a Project Manager to lead INA, NDA, and BLA filings to the FDA: developing and maintaining submission timelines, prioritizing workload and driving the team to develop the NDA content, coordinating and leading cross functional team meetings, identifying, mitigating and resolving project risks and issues
Developing and executing CMC strategies for new product development and product enhancements
Leading CMC and post-licencing compliance initiatives; working with manufacturing sites and in-country offices to develop remediation strategies.
Taking the lead in CMC Dossier authoring and submission, coordinating a global team of CMC consultants.
Understanding and evaluating complex information and seeking to build on knowledge and understanding. Keep up to date with international legislation, guidelines and customer practices.
A day in the life of a G&L consultant is a varied one – your daily workload will shift according to client priorities and workload – so we find that no week is the same and there is no time to get bored! G&L people are typically excellent communicators, selfless team players, and brilliant multitaskers. Cultural match is incredibly important to us: we have a collaborative and supportive team – there is no place for politics or empire building. 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.
For our current openings, we are looking for the following criteria:
5 – 15 years broad regulatory experience, ideally spanning biotechnology, pharmaceuticals, devices and consumer healthcare products. Our projects are diverse – so we are looking for someone who can turn their hand to anything!
Experience of managing large teams – acting as mentor to junior staff, developing individual training programmes. Our company is all about our people – so you should have a passion for meritocracy, recognition and development.
Experience of working in client-facing environment, experience of designing, running and executing bespoke client projects. Experience of managing projects, including resource management, budgeting, timelines and deliverables.
Extensive experience of US and ROW regulatory affairs including development, regulatory strategy and in-depth knowledge of CMC. Ideally experience of European procedures (as well as direct contact with the Health Authorities. You will represent G&L to our clients and the agencies – so interpersonal skills are paramount.
We are looking for new team members who can start immediately / Q2 2018. If you would be interested in joining the team at G&L Scientific, please send your CV to firstname.lastname@example.org 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. 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 behaviour and promote equality of opportunity.
Internal Number: G_LMay
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.