Regulatory Affairs Specialist
Alkahest is a clinical stage biopharmaceutical company targeting neurodegenerative and age-related diseases with transformative therapies derived from a deep understanding of the plasma proteome in aging and disease.
The Regulatory Specialist will report to the Director, Regulatory Affairs and support regulatory activities critical to the company’s product development objectives. These may include preparing regulatory documents, serving as the regulatory representative on assigned clinical trials, providing input into the development of processes and timelines in support of designated regulatory activities, and tracking submissions.
Alkahest offers a competitive compensation and benefits package, annual bonus potential, opportunities for career growth and development, and a work environment that is collaborative, collegial and lots of fun.
Responsibilities include (but are not limited to) the following:
- Serve as regulatory representative for designated clinical trials
- Maintain IND and prepare documents for IND submissions (cover letters, forms, IND annual reports, IB annual updates)
- Assist with preparing clinical trial applications (CTA) and investigational new drug applications (IND)
- Post and maintain record of studies on ClinicalTrials.gov
- Perform in depth review of study documents and track status of submissions
- Review investigator packages and authorize drug shipments to clinical sites
- Assist with internal review of regulatory deliverables and development of submission timelines
- Use tools to track and manage regulatory commitments, submissions, and correspondence
- Ensure quality, consistency, completeness and accuracy for all regulatory submissions
- Assist Regulatory department in the update, enhancement, and creation of internal policies, working practices and procedures.
- Minimum of a bachelor’s degree, in the life sciences preferred.
- Minimum of 4 years regulatory experience, international experience desirable.
- Experience working with CROs on regulatory submissions in support of clinical trials
- Knowledge of current Global (FDA, EMA) regulations and guidance of requirements for investigational products, IND and CTA submission requirements
- Experience with cloud-based document management programs (e.g., Arivis) and/or document management systems is preferred
- CMC experience desirable but not required
- Experience with EU CTA submissions is desirable
- Ability to work well and foster collaboration within cross-functional teams
- Strong verbal/written English communication skills
- Attention to detail; ability to manage multiple projects as well as organize and prioritize activities
- Organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously
Apply today. We'd love to meet you!