In partnership with Discovery R&D project and Safety Pharmacology teams, prepare non-clinical regulatory documents which will be used to support global clinical trial and marketing applications. The Discovery regulatory submission coordinator will be responsible for ensuring the standardization of Discovery pharmacology reports across Discovery sites, the coordination and quality assurance of summary documents submitted to global regulatory agencies, and the management of non-clinical regulatory timelines for multiple assets. The Discovery regulatory submission team works collaboratively with Discovery Project teams, DMPK, Toxicology, and Regulatory Affairs Project Management. The Discovery regulatory submission team is responsible for ensuring the incorporation of non-clinical pharmacology into global regulatory filings through the regulatory submission process. By having knowledge of both drug discovery and the regulatory submission process, the coordinator is in the unique position to ensure that regulatory submissions supporting clinical trials proceed in a timely manner.

Major Responsibilities:

• As the Discovery primary contact, responsible for the management of non-clinical regulatory deliverables for global regulatory submissions.
• Collaborate with Discovery project teams, Development Science, Clinical Medical Writing and Regulatory Affairs to ensure timely delivery of accurate, standardized non-clinical regulatory documents across all Discovery sites
• Write and ensure quality of reports, IB, IND, IMPD and NDA scientific summaries and coordinate queries from regulatory agencies
• Works independently and with oversight of a Project Manager to meet timelines and deliverables.
• Monitors and motivates project teams and influences across the R&D organization to ensure timely and high-quality regulatory submissions
• Appropriately handless confidential information.

Requirements

• Degree in Biology (pharmacology, molecular biology, or biochemistry) or a related field.
• PhD and typically 0-4+ years of experience
• Masters and typically 5+ years of experience
• Bachelors and typically 7+ years or 10-15 years equivalent work experience
• This role requires a scientific background with experience; preferentially in a drug discovery laboratory and familiarity with the drug discovery process.
• Able to manage multiple projects concurrently and continually reassess the priorities and deadlines.
• Problem solving skills essential for addressing both scientific and logistical challenges. Must be able to work independently to resolve problems and develop recommendations.
• Requires excellent computer skills such as: Word, Excel, Smartsheet, SharePoint, and PowerPoint

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.