This position reports to the Vice President, Regulatory Affairs and Quality and has the overall responsibility for managing pre and post marketing regulatory activities for all company products.

·         Prepare and submit regulatory submissions to the FDA.  These submissions include original new drug applications (NDAs and INDs), amendments, supplements, FDA meeting requests and briefing packages.

·         Lead the electronic submission process.

·         Ensure that all submission and other RA software licenses are current.

·         Review and approve required CMC, Clinical, and Nonclinical reports, supplemental submissions and other postmarketing commitments to update and maintain product approvals and registrations.

·         Provide training on current and new regulatory requirements to ensure company-wide compliance.

·         Communicate the impact of new, existing and pending regulations, guidelines and standards to internal stakeholders.

·         Review and approve labeling updates.

·         Review and approve promotional materials for submission to OPDP.

·         Submit/review change controls to determine the level of change and consequent submission requirements.

·         Provide regulatory input for product recalls and recall communications.

·         Manage systems to ensure that adverse events and product safety issues are reported to regulatory agencies.

·         If required, negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

·         Assess the acceptability of quality, CMC and clinical documentation for inclusion in regulatory submissions.

·         Keep an accurate and up-to-date record of all submissions, CRL, PAS and all other regulatory communications with FDA.

·         Formalize and establish Regulatory Standard Operating Procedures, as required, and maintain current records.

·         Consult with internal stakeholders and external partners to identify and review documentation required to address regulatory issues.

·         Interact with outside organizations that might assist with regulatory needs such as those that assist in preparing SPL, external auditors, and consultants.

·         Assist during FDA inspections and audits, as required.

Minimum Requirements:

·         Bachelor’s degree or higher in Pharmacy, Chemistry, Biology or related field with 6 to 10 years of pharmaceutical regulatory affairs experience

Preferred Requirements:

·         Knowledge of ICH guidelines and FDA guidance documents relating to  work description

·         Proven ability of attention to details

·         Strong oral and written communication skills

·         Knowledge of GMP regulations

·         Knowledge of CFR regulations pertaining to NDAs and ANDAs

·         Knowledge and skilled at using e-CTD submission software. 

Other Skills/Abilities:

·         Ability to maintain high degree of confidentiality

·         Excellent interpersonal and written communication skills

·         Ability to work independently

·         High proficiency in database/spreadsheet programs: Excel, Word, PowerPoint, and ability to learn new programs as needed

·         Exhibit positive, constructive, decisive demeanor

·         Excellent follow-up skills; demonstrated ownership to provide real resolutions

·         Ability to be flexible in workload supporting department

·         Excellent organizational skills and detail oriented

·         Maintain accurate documentation

·         Ability to multi-task

Physical Requirements:

·         Position may require some travel

·         Position includes working in a fast-paced team-based environment.