Cambridge, MA - United States
Seeking a strong and experienced candidate to hit the ground running to provide support to an established and growing regulatory group. Someone who's confident and independent in providing regulatory guidance and critical review of documents for global submissions to regulatory authorities. Someone with a strong FDA and Health Canada background is most important. Must have a proven track record of success with managing multiple projects while ensuring that submissions meet all current regulations.
Assist in overseeing project submission planning and managing timelines, schedules and regulatory submission processes.
Provide regulatory support for the review of clinical protocols, informed consent forms, Investigator's Brochures, CMC and site documentation.
Provides regulatory operations expertise and leadership to the cross-functional teams in a representative function supporting both pre-market authorizations and post-approval activities.
Oversees and prepares documentation to support regulatory filings to ensure accuracy, applicability, consistency, and control of regulatory documents. Interacts with SMEs for accuracy of content.
Assist the Regulatory Lead in meetings for Response to Heath Authority requests, content verification and follow-ups with functional leads.
Provide direct regulatory eCTD publishing and submission support to the following: INDs, CTAs, IMPDs, NDAs, JNDA/BLAs, and other regulatory submissions
Stay current and monitors any changes in regulations and keeps project teams and management informed of such changes as well as maintains familiarity with current and future global regulatory submission standards.
B.S. degree in life sciences with a minimum of 8 years pharmaceutical industry experience
At least 8-10 years Regulatory Affairs and/or Regulatory Operations experience
Working knowledge of US and international regulations (i.e.: cGMP, GCP, GLP, ICH guidance documents)
Experience with Veeva RIM/enterprise document management systems (eDMS)
Strong Knowledge of eCTD publishing and submissions experience is required
Strong ability to work and manage multiple projects at any given time
Key skills: Excellent communication skills, both written and verbal communication, also excellent organizational skills. Professional, proactive demeanor and strong interpersonal skills
If interested in learning more, please contact Bria Gaber at firstname.lastname@example.org or (646) 430-1191 for more information.