Our client is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. They are seeking a Senior Regulatory Submissions Contractor/ Consultant (Associate Director or Director level) who can lead submission planning and execution for their first BLA and other filings. Reporting into the SVP of Regulatory, you will manage regulatory submissions and work closely with project teams. This remote engagement will be approximately 20-25 hours a week for 1-2 years.
Responsibilities:
- Lead and manage timely regulatory submission activities (planning, authoring, editing, reviewing, coordination, submission) including applications and correspondence with regulatory agencies (meeting requests, briefing documents, responses to regulatory authorities, etc.)
- Provide strategic, tactical and operational guidance to cross-functional project teams and share information regarding regulatory requirements.
- Ensure guidance with regulatory requirements.
- Contribute to the planning, coordination, preparation, and review of regulatory submissions, including those related to Agency meetings, as needed.
- Work collaboratively with internal stakeholders to ensure that regulatory standards and compliance are considered throughout the program lifecycle
- Strategize, plan, and implement regulatory activities with focus on late-stage programs.
- Provide day-to-day guidance to writers and reviewers on manufacturing, clinical and nonclinical content for INDs and amendments, and other regulated documents such as Investigator Brochures, Protocols, Pharmacy Manuals, SOPs.
- Continually monitor the regulatory environment to maintain expertise in regulatory principles, landscape changes, competitive products, and implications.
- Perform regulatory intelligence as necessary.
- Engage in continuous improvement initiatives for regulatory affairs processes and/or activities.
Qualifications:
- Bachelor’s degree in life sciences.
- Seven or more years of applicable Regulatory submission experience working in a biotechnology or pharmaceutical organization.
- Two or more years of regulatory submissions experience working in later-phase product development programs leading to marketing applications (BLAs or NDAs) and beyond.
- Proven track record of successful regulatory submissions to FDA including regulatory documents, eCTD documentation and FDA correspondence.
- Experience with biologic applications including BLA filings and pre-BLA meetings highly desired.
- Experience with regulatory submissions to Ex-US/Global agencies a plus (Canada, Japan, EMA).
- Working knowledge of the drug development process is required
- Experience in Labeling and package insert development is a plus.
- Excellent understanding of requirements, context, and content of regulatory submissions.
- Demonstrated ability to understand and interpret regulatory requirements and translate this into concrete propositions.
- Working knowledge of Agency regulations and industry standards.
- Excellent oral and written communication skills are required.
- Ability to lead and manage projects to completion and experience working in project teams.
- Ability to work in a flexible environment to meet regulatory and corporate goals.
- Strong interpersonal and organizational skills.
- Must be comfortable in a small company environment.
This is a remote engagement, but East Coast candidates are preferred.
Note: All contractors must be authorized to work in the United States. H1B sponsorship is not available.