Regulatory Affairs Consultant – CMC Biotech
G&L has an opportunity for a senior Regulatory professional with a strong background in CMC and biotechnology.
Our UK team, which is based in West London, has a number of projects with requirements in the coming months.
Our projects are diverse, and we are considering all regulatory talent for our upcoming openings, which will include biotechnology and pharmaceutical as well as development and approved products.
The Role
As a G&L consultant, you will be working with a variety of clients and your duties may include the following:
- Developing submission strategies and planning for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
- Evaluating change controls and providing regulatory assessments to classify quality changes in production and quality control.
- Supporting client project teams in the preparation of the CMC sections of all submission content to facilitate approvals and continued compliance.
- Reviewing key study reports (e.g., process validation, stability studies, analytical method validation) to ensure regulatory compliance.
- Developing and maintaining high-quality, realistic Chemistry, Manufacturing & Control (CMC) plans for products in development.
- Maintaining a positive and productive liaison with internal and external contacts. This may include clients, regulatory agencies, and related institutions.
- Attending formal interactions (face-to-face meetings, teleconferences, etc) with clients and possibly government agencies. Building positive working relationships with clients.
- Identifying gaps and risks in the CMC plans and working with the team to proactively develop solutions that will increase efficiency and minimise timelines.
- Assisting in the development of assessments and strategic regulatory plans for client product development programs.
- Reviewing CMC sections of BLA submissions and preparing gap analysis detailing requirements for submission to different jurisdictions.
- Participating in project teams and advising other departments on CMC regulatory issues and strategies, including manufacturing, supply chain, quality control, quality assurance, and other regulatory and local entities.
- CMC authoring of Module 2.3 and Module 3 sections of the CTD dossier.
Requirements
- 5-10 years working knowledge of CMC regulatory Affairs, including a minimum of 3 years working with Biotechnology products
- Experience in authoring technical / CMC parts of regulatory documents
- 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.
- Working knowledge of RIM Systems, including Veeva Vault
- Proficiency in MS-Office applications, including Microsoft Word, Excel and PowerPoint.
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.
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