Under the direction of the Sr. Director, Regulatory and Quality Systems, the Regulatory Affairs Manager ensures that regulatory requirements set forth in client’ NDAs and ANDAs are properly maintained, is aware of current and upcoming regulatory requirements related to submissions to the FDA.
Author, compile, and prepare regulatory supplements to USFDA (e.g. Labeling, Prior Approval Supplements, CBE-30, CBE-0, Annual Reports, and USFDA inquiries) in electronic (eCTD) formats in accordance with regulatory requirements and electronic submission specifications.
Coordinate with Manufacturing, QA, contract service providers (e.g. manufacturers, laboratories, packagers, etc..) to compile the necessary documents for regulatory submissions to support the CMC sections of the registrations dossier.
Prepare, submit, track, index, and archive paper and electronic submissions as well as regulatory correspondence in a timely manner.
Participate as a member of the Tech Transfer Team to ensure awareness of regulatory requirements as well as the timing and accuracy of submissions.
Ensure labeling content is developed in accordance with regulatory requirements as well as assisting in the coordination of label review and approval.
Review and assess the regulatory impact of changes related to client products.
Develop and/or update CMC Regulatory SOPs when necessary.
Maintain internal Regulatory documentation files, databases, and logs.
BS degree technical/scientific discipline with a minimum of 5 years Regulatory Affairs (CMC) experience in the pharmaceutical industry. Advanced degree in a scientific discipline is desirable.
Must be detail oriented with the ability to proof read and check documents as well as labeling for accuracy.
Able to develop and maintain collaborative relationships with internal and external business partners.
Must have strong communication skills (both, verbal and written) at all levels within an organization.
Able to work with a sense of urgency, prioritize work, meet corporate objectives and deadlines with strong organizational capability.
Able to adapt to change and work flexibly.
Strong project management skills with the ability to work independently and within a team
Proficient in computer skills such as Microsoft Office; Word, Excel, Powerpoint etc.
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: 1000
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.