Associate Director, Regulatory Affairs
Description
Position Overview:
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.
Equal Opportunity Employer Women/Minorities/Disabilities/Veterans
Any communication you receive from Mayne Pharma will never come from a personal email domain or chat service such as "gmail" or "Google Chat". All official communication from Mayne Pharma will be received from our company email domain - @maynepharma.com.