Associate Director/Director Strategy
2 weeks ago
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
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