Job Title: Manager, Regulatory Affairs
Location: Emeryvilla, CA
Position Type: 6 month contract role with possibility of extension or conversion depending on fit and client need
The Manager, Regulatory Affairs provides assistance with clinical trial applications, which includes investigational new drug applications and clinical trial applications, and ongoing trials and post approval activities.
The Manager supports regulatory activities and supports the study management team with authoring and reviewing all materials required in submissions.
- Serve as Regulatory Lead on Study Teams
- Provide Regulatory guidance, resolve study management issues or present issues back to RA accordingly
- Review investigator packages and authorize drug shipments to clinical sites
- Independently prepare submission documents for IND submissions (cover letters, forms, IND annual reports, IB annual updates)
- Ensure the quality, accuracy and format of CTA and IND regulatory submissions and other documentation comply with applicable laws, regulations, and company standards
- Facilitate project team meetings for allocated programs
- Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures
- BS degree and 5+ years of experience in the pharmaceutical industry, an advanced degree will be considered in lieu of industry experience
- 5 years in regulatory affairs; international experience desirable
- Computer skills, attention to detail, and ability to multitask
- Organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously
- Able to communicate and interact effectively within department, and across departments
- Possesses a thorough knowledge of current Global (FDA, PMDA, EMA) regulations and guidance of requirements for investigational products, IND and CTA submission requirements
- Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player.
Sr. Sourcing Specialist
**If this is not a fit for you or you are not interested, Ascent offers an excellent Referral Bonus! We look forward to hearing from you!
Ascent is a nationally recognized technology staffing and consulting firm whose fundamental business is providing staffing services to Small, Medium, and Large Enterprise clients in our core market verticals: Financial Services, Healthcare, Technology and Life Sciences. As consultants for Ascent, you will have access to many of the top clients within the industries we serve. Our goal is to deliver innovative talent through proven best practices and effective resource optimization. Become one of Ascent’s candidates and experience the difference!