Director/Senior Director Regulatory Affairs – US/Global RA Strategy
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 Senior Regulatory strategist to join our global team.
This role is a senior position that combines technical regulatory, commercial and business strategy, project management, and client relationship management.
Based in North America, this is a permanent career opportunity.
- Planning and executing complex regulatory tasks and activities as required by G&L Scientific’s broad spectrum of clients across the healthcare industry.
- Leading and managing regulatory strategy aspects of a variety of client projects across the product lifecycle, including the development of new and existing pharmaceutical and biologics products.
- Preparing and submitting correspondence and applications to regulatory agencies. Acting as a direct liaison between global regulatory authorities and G&L’s clients to facilitate the effective review and approval of applications.
- Having a broad knowledge of regional regulatory environments; Providing support for our client’s global regulatory strategy requirements, aligning with regional and global business needs.
- Developing and executing regulatory strategies for the development of new and existing pharmaceutical and biologics products.
- Leading and guiding clients through global regulatory pathways including CTA/IND, MAA/NDA/BLA, supplements/variations, license renewals etc.
- Leading and providing regulatory input to cross-functional project teams.
- Coordinating Health Authority meeting preparation (prepare or review meeting requests, briefing books, rehearsals, response to FDA questions) and participating in agency meetings.
- Interpreting new or existing regulatory requirements relevant to assigned products and projects.
- Preparing or reviewing Orphan Designation applications and Breakthrough applications.
- Supporting both early- and late-stage clinical development activities by providing regulatory guidance and advice.
- Providing technical input and support during RFI and RFP client business processes, scoping projects for budgets and timelines.
- Using previous experience to provide technical input and support during RFI and RFP client business processes; scoping projects for budgets and timelines.
- Scientific degree. An advanced degree (MSc, MBA or PhD) may be an advantage but is not essential.
- Working knowledge of many therapy areas would be an advantage, including Oncology, Ophthalmology, Immunology, and Large Molecule.
- A minimum of 10 years’ experience in a similar role.
- Experience of US, EU & global regulatory affairs.
- Demonstrable ability to manage complex regulatory issues.
- Proven ability to deliver to agreed timelines, budgets, and quality standards.
- Strong strategic thinking, project management, teamwork, and problem-solving skills.
- Impeccable communication and interpersonal skills to include public speaking duties.
- Ability to influence and offer consulting at all levels of G&L and external stakeholders.
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.
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