G&L Scientific is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions.
As demand for our services and solutions continues to increase, we have an exciting new opportunity for a Clinical Regulatory professional to join our global team.
Based in North America, this is a permanent career opportunity.
This role is a senior position that combines technical regulatory, commercial and business strategy, project management, and client relationship management.
Typical duties will include:
- Providing the highest quality of senior-level, regulatory consultancy to G&L’s clients.
- Applying in-depth knowledge of regulatory requirements and guidelines, procedures and best practices, including compliance.
- Working on assigned projects where you will act as a consultant to our clients and provide advice and input on Regulatory Affairs project work.
- Representing G&L’s clients to Health Authorities, e.g. FDA, and working closely with client affiliates’ offices.
- Providing experienced stakeholder management as directed by G&L’s clients.
- Working with a variety of internal and external stakeholders.
- Life Sciences degree.
- 5-10 years of experience in a similar role within the healthcare industry.
- Experience in US, EU & global regulatory affairs.
- Experience and knowledge of multiple therapy areas.
- Experience in regulatory affairs (US, EU, ROW) including submission requirements and Health Authority interactions.
- Knowledge of GxP, ICH, and other regulatory guidelines; experience in providing regulatory assessments and guidance including considering precedence and relevant HA guidance through many project-level activities.
- Knowledge and experience of the drug development process from IND/CTA opening through final product approval, and how other functions contribute to a regulatory submission (IND/CTA/IMPD, NDA/BLA/ANDA/MAA, etc.).
- Impeccable communication and interpersonal skills.
- Strong strategic thinking, project management, teamwork, and problem-solving skills.
- Competence in strategic agility, communication, leadership, pharma drug development, and organizational and business knowledge.
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.