Regulatory Strategist, 1099 contract role, US-based
As a valued provider of strategic advice to small biotech and start-up companies for many years, demand for our services and support is constantly high.
As a result, we regularly require the support of consultants for niche project work, peaks and troughs in workload, and specialist therapy areas.
We are currently seeking exciting new talent to join our global network.
The Role
Typical project work will include some of the following tasks and responsibilities:
- 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 FDA and health authorities.
- Acting as a direct liaison between global regulatory authorities and G&L’s clients to facilitate the effective review and approval of applications.
- Providing support for our client’s global regulatory strategy requirements, aligning with regional and global business needs.
- Regulatory Strategy, Regulatory Pathway, Clinical Strategy, Clinical Development.
- Developing Paediatric Plans, Orphan designations or Breakthrough Submissions for submission to the FDA.
- Working on new Product development projects.
- Working on Phase 1 (I), Phase 2 (II), and Phase 3 (III) clinical study/ studies.
- Preparing or reviewing IB (Investigator Brochure), study Protocol, and CSR (Clinical Study Report).
- Handling FDA liaison including preparing for and participating in FDA Meetings, Meeting Requests, and Briefing books (Pre-IND, EOP-2, Pre-NDA, Type B, Type C meetings).
- Safety Reporting/Post-marketing surveillance/DSUR/ PSUR
- Supporting early- and late-stage clinical development activities by providing regulatory guidance and advice.
Requirements
Our ideal consultant will have:
- A broad range of development experience,
- Excellent diplomacy and negotiation skills,
- A flexible and adaptable approach to their workload, and
- Previous experience working with stakeholders from a variety of regions and functions.
You will be planning and executing complex regulatory tasks and activities as required by G&L’s broad spectrum of clients across the healthcare industry.
How to Apply
If you would like to hear more about the projects that we are currently working on, please get in contact today with our resourcing team.
We have a variety of projects, some are ad-hoc in nature, and others are regular working hours; we can identify opportunities that suit your availability.
G&L Healthcare Advisors 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.