Proclinical is currently recruiting for a GRL Director with a global biotechnology company located in Washington, DC. As the GRL Director, you will provide global regulatory leadership regarding biosimilar development and management of submission related documents, regulatory data for Biosimilars.
- Lead preparation, rehearsal and manages meeting with Health Authorities.
- Develop, supervise and manage the submission strategy of Biosimilar dossier that best serve the biosimilars business needs, whilst ensuring the work is done in compliance with regulatory procedures and systems. Ensure the regulatory strategy is endorsed by the Development Team and the Project Development Committee.
- In alignment with the Development team, establish necessary regulatory storyline for regulatory interactions (briefing book consultations and submission dossier).
- Provide global guidance and support to Market Units in their interactions with local health authorities (life cycle management) including mapping of regulatory constraints and contribution to wave 2 launch prioritization.
- Contribute to the Global Launch Readiness team by providing detailed understanding of the regulatory process and by guiding the team on the best regulatory approach (e.g. Labelling, packaging, artworks).
- Lead the Regulatory Sub-team.
- Serve as Regional Lead, dependent on location, i.e., US-based GRLs take on US-lead responsibilities, Switzerland-based GRLs take on EU-lead responsibilities, including direct interaction with FDA, EMA respectively.
- Manage regulatory submission process through to approval.
- Manage regulatory agency interactions, document preparation, co-ordinates rehearsals and minutes.
- Serve as an interface between other regulatory groups and company functions as appropriate.
Skills and Requirements:
- Bachelor's Degree in life science or related disciplines.
- At least 10 years in international regulatory affairs function required.
- Experience in managing international or regional regulatory submissions, normally a full global submission (new product application), preferably US BLA.
- Experience in working in development project teams.
- Experience in leading regulatory agency interactions including management of the associated documentation and rehearsals.
- Experience in preparation and coordination of regulatory strategy plans.
- Experience in biological development.
- Capability to manage a number and range of projects throughout development.
- Excellent written and spoken communication skills.
- Excellent interpersonal skills.
- Understanding of Regulatory Affairs contribution to Pharma business.
- Excellent organizational skills, work independently, self-motivated and proactive.
- Ability to think strategically.
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or email@example.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.