The Company is a Pharmaceutical company that has a great underdog story. They started as a generic company until they hired a new CEO who has turned the company around. They went from struggling to now 3x their stock. Their main focus is on women's health.
Join our team as a Director Regulatory Affairs, reporting directly to the Vice President of Regulatory Affairs and Quality. In this role, you will oversee all pre and post-marketing regulatory activities for our company's product portfolio. This is a pivotal position where you will contribute to ensuring compliance with regulatory requirements and maintaining product approvals.
Key Responsibilities:
- Prepare and submit regulatory filings to the FDA, including new drug applications (NDAs and INDs), amendments, supplements, meeting requests, and briefing packages.
- Lead the electronic submission process and ensure the currency of all submission and regulatory affairs software licenses.
- Review and approve essential CMC, Clinical, and Nonclinical reports, supplemental submissions, and post-marketing commitments to uphold product approvals.
- Conduct training sessions on current and emerging regulatory requirements to foster company-wide compliance.
- Communicate the implications of new, existing, and pending regulations, guidelines, and standards to internal stakeholders.
- Review and approve labeling updates and promotional materials for submission to OPDP.
- Assess change controls to determine submission requirements and provide regulatory input for product recalls and recall communications.
- Oversee systems for reporting adverse events and product safety issues to regulatory agencies.
- Interact with regulatory authorities during the development and review process to facilitate submission approval, if necessary.
- Evaluate the suitability of quality, CMC, and clinical documentation for inclusion in regulatory submissions.
- Maintain accurate records of all submissions, communications with the FDA, and regulatory interactions.
- Establish and formalize Regulatory Standard Operating Procedures as needed, ensuring current documentation.
- Collaborate with internal teams and external partners to gather necessary documentation to address regulatory issues.
- Engage with external organizations to support regulatory needs, such as preparing SPL, external auditors, and consultants.
- Provide assistance during FDA inspections and audits as required.
Qualifications:
- Bachelor's degree in a relevant field; advanced degree preferred.
- Several years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Thorough understanding of FDA regulations and submission processes.
- Strong communication skills, both written and verbal, with the ability to effectively engage with internal and external stakeholders.
- Excellent organizational skills and attention to detail.
- Proficiency in managing regulatory software and electronic submission platforms.
Benefits:
Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Employer-Paid Basic Life Insurance
- Supplemental Life Insurance
- Employer-Paid Short-Term Disability
- Long-Term Disability
- 401(k) Plan
- Paid Time Off
- Paid Holidays
