Proclinical is seeking a Regulatory Affairs Specialist who is passionate about contributing to regulatory strategies for various projects for a CMC Consultant role.
Primary Responsibilities:
The ideal candidate will have a strong understanding of current pharmaceutical and GMP regulations, laws, and guidelines in the US and internationally. This role requires the ability to multitask, work on several projects at different stages of development, and execute document preparation with accuracy.
Skills & Requirements:
A minimum of a BS in a Life Sciences discipline.
Proficiency in MS Word and Excel. Familiarity with SharePoint, eCTD templates, and Adobe products.
Excellent technical, written and oral communication skills.
Ability to multitask and handle multiple projects concurrently.
High attention to detail and team-oriented.
The CMC Consultant's responsibilities will be:
Contribute to regulatory strategy for projects based on FDA Guidances and 21 CFR.
Prepare technical documents and packages for regulatory submissions, including meeting requests and briefing packages.
Support the authoring of sections of INDs/CTA/NDA/BLA/MAAs from technical or scientific source documentation.
Transcribe, format, and summarize CMC data and information accurately and consistently.
Adhere to project timelines and budget requirements.
Promote and demonstrate collegiality with all company members.
Participate in training and development programs.
Communicate effectively and work efficiently with clients and company members in a virtual environment.
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1)646-367-2908 or n.walker@proclinical.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.