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Executive Director Regulatory Affairs

Insight Recruitment Sioux Falls, SD

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

We are an award-winning immunotherapy company, focused on identification, development and manufacture of treatments for a variety of human diseases.  With multiple therapeutics in the pipeline, including a treatment for Covid-19, we are searching for an Executive Director of Regulatory Affairs to join our growing team!

In this new role, you will ensure that regulatory compliance is being upheld throughout the drug product development life cycle.  The successful candidate has led the strategy, preparation, review and submission of documents to the FDA to support product development of new biologics.  You will have the opportunity to work with a one-of-a-kind technology that enables treatment solutions for people infected with critical pathogens.

Located in Sioux Falls, SD, we offer a salary up to $150k plus stock options, bonus and great benefits. Its a great time to join our company as we are poised for significant growth and offer lots of opportunity for advancement!

Responsibilities:

Provide efficient and effective regulatory representation across the organization and act as the liaison in interactions and communications (meetings, phone calls, etc.) with the Food and Drug Administration (FDA) as needed. Prepare summaries of meetings for inclusion in regulatory archives.

Provide guidance for, and actively contribute to, the development of regulatory submissions, which may include Investigational New Drug (INDs) applications, briefing documents, orphan drug applications, breakthrough designations, Emergency Use Authorization requests and Biologics License Applications (BLAs), ensuring that they meet current regulatory requirements and industry standards.

Assess acceptability of quality, preclinical and clinical documentation for regulatory submissions.

Identify and develop new company regulatory policies, procedures and SOPs and general trainings for Executives and Upper Management and more specific trainings for regulatory staff.

Develop regulatory strategy plans with specific deliverables and timelines and integrate business and clinical objectives with regulatory requirements.

Manage inspections and audits by regulatory authorities and accompany inspection team(s) as required. Provide input for follow-up to inspections and audits to minimize potential findings of non-compliance.

Oversee labeling, advertising and promotional material review to ensure regulatory compliance.

Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events including reporting of adverse events and providing input for product recalls and recall communications.

Review change controls to determine the level of change and consequent regulatory submission requirements.

Manage and ensure compliance with all regulatory reporting requirements, including annual and periodic reports and maintain annual licenses, registrations and listings.

Evaluate proposed preclinical, clinical and manufacturing changes for regulatory impact and risk and identify filing strategies. 

Collaborate with Quality Systems regarding issues of manufacturing, assay development, equipment and process validations. 

Independently provide phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for INDs and BLAs for development projects.

May provide regulatory leadership for due diligence activities.


Requirements:

Minimum of 10 years of experience in regulatory affairs with 1 or more biopharmaceutical or pharmaceutical companies

Masters degree in scientific field preferred

Expertise in GMP requirements for clinical, manufacturing and quality practices

Leadership experience in the establishment of INDs and approvals of BLAs.

Regulatory certifications preferred

Its a great time to join our organization and directly impact global human health!


Insight Recruitment

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Sioux Falls, SD
USA

Industry

Government

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