G&L is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients worldwide with expert Regulatory Affairs consultancy solutions.
As demand for our services and solutions continues to increase, we have an exciting new opportunity for an experienced Associate Manager, Regulatory Executive in our Paddington office.
This role will commence in Quarter 1 of 2023.
Joining G&L’s core team of Regulatory Affairs colleagues, the successful candidate can expect to work on a succession of client projects, from the top pharma, biotech, and generics corporations to smaller companies, start-ups, and university spin-offs.
You will be part of a network of global consultants, working with a diverse team of internal junior and senior colleagues and external client stakeholders.
We are looking for a team member who is happy to get involved in a variety of activities – from client project work to training junior colleagues and embracing the extra-curricular aspects of our company.
Working for G&L is more than just a job – we strive to foster collaboration, ingenuity, and professional happiness.
- Preparing CMC regulatory documents and/or other regulatory documents for MAA and Post Approval Lifecycle projects including renewals, variations, annual reports, etc.
- Proactively working with manufacturing sites on change control projects and providing regulatory advice and strategic guidance.
- Authoring and contributing to marketing authorization applications.
- Managing multiple projects simultaneously and providing data assessments and conclusions.
- Mentoring and supporting junior team members, providing informal and formal training as required.
- Identifying risks associated with submission data and information packages, and proposing mitigation plans.
- Leading interactions with customers and senior stakeholders as required.
- Identifying and implementing improvement opportunities for Regulatory processes, policies, and systems.
- Responsibility for process improvement and regulatory intelligence projects.
- Between 6-10 years of working experience in Regulatory Affairs.
- Previous experience working for a consultancy company would be beneficial.
- Small and large molecule experience, ideally across multiple therapy areas/dosage forms.
- Impeccable communication and diplomacy skills.
- Ability to lead and manage project teams, adopting matrix management.
- Willingness to line manage junior colleagues and assist with training and development programs.
- Able to work at G&L’s offices for a minimum of 2 days per week.
For further details, please send your CV to: firstname.lastname@example.org
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 the threat of discrimination, intimidation, harassment, and abuse.
All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity