- 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.
- Bachelor's degree or higher in Pharmacy, Chemistry, Biology or related field with 6 to 10 years of pharmaceutical regulatory affairs experience
- 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.
- Ability to maintain high degree of confidentiality
- Excellent interpersonal and written communication skills
- Ability to work independently
- 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
- Position may require some travel
- Position includes working in a fast-paced team-based environment.
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Associate Director, Regulatory Affairs - Raleigh, United States - Mayne Pharma
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.
High proficiency in database/spreadsheet programs:
Excel, Word, PowerPoint, and ability to learn new programs as needed
Any communication you receive from Mayne Pharma will never come from a personal email domain or chat service such as "gmail" or "Google Chat".
Associate Director, Regulatory Affairs professionals in Raleigh
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Stephanie Ladd
Senior Clinical Research Professional
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Jose Severino
Quality is my priority.