Role posted on: 23rd October 2018
G&L have a number of opportunities for Regulatory professionals with a strong background in CMC. Our US team, which is based on both East and West coasts, has multiple projects with requirements in the coming months. Our projects are diverse and so we are considering all CMC talent for our upcoming openings, which will include consumer health, biotechnology or pharmaceutical products, as well as development and approved products.
Role Description: CMC Regulatory Consultant – US nationwide
- Supports project teams in the preparation of the CMC sections of all submission types in adherence with applicable legislation, regulations and guidelines facilitating approvals and continued client compliance.
- Maintains a positive and productive liaison with internal and external contacts. This may include clients, regulatory agencies, and related institutions.
- Attends formal interactions (face-to-face meetings, teleconferences etc) with clients, and possibly, government agencies. Builds positive working relationships with clients.
- Assist with the CMC section of clinical trial applications for both small and large molecules and natural health products.
- Assists in the development of assessments and strategic regulatory plans for client product development programs. Review CMC sections of client prepared submissions and preparation of gap analysis detailing requirements for submission to different jurisdictions for manager review.
- Participate in and support project teams and advise other departments on CMC regulatory issues and strategies.
- Quality review (technical and editorial) CMC section of regulatory submission prepared by team member(s)
- Previous relevant experience, i.e., pharmaceutical, biologics, natural health products with regulatory experience in the local environment is preferred.
- In depth understanding and experience with regulatory submissions.
- Ability to prepare submission documents independently
- Ability to interpret applicable statutes, regulations and guidance documents needed to prepare regulatory submissions and develop regulatory strategy with guidance.
- Understand applicable laws, regulations and guidance documents needed to prepare regulatory submissions with guidance.
- Knowledge of Health Canada, FDA, EMA and International Conference on Harmonization practices, regulations and guidelines and implementation into regulatory filings; integration of CMC data into regulatory and quality documents.
- Ability to maintain a high level of accuracy and attention to detail
- Problem solving, judgment and decision-making skills to seek creative solutions to issues surrounding on-time, on-budget and high-quality project outcomes
- Excellent planning, organization, interpersonal, time and change management skills.
- Proficiency in MS-Office applications including Microsoft Word, Excel and PowerPoint.
If you would be interested in joining the team at G&L Scientific, please send your CV to talent @ gandlscientific.com today.
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.