Manager​/Sr Manager, Regulatory Affairs

Overview

Precigen is a dedicated commercial stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

Precigen has developed novel manufacturing processes to deliver Ultra

CAR-T® and Adeno Verse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.

As the Senior Manager Regulatory Affairs, you will be a key member of a small, dynamic, and fast-paced Regulatory team who will support the Associate Director, Regulatory Affairs with creating regulatory submissions in compliance with regulatory standards and guidelines and maintaining controlled documents.

This will be an onsite role in our Germantown, Maryland facility.

• Lead CMC Regulatory execution for specific programs at all stages of development
• Provide strategic Regulatory input to the Manufacturing and Quality organizations pertaining to global product development requirements
• Lead the development of CMC documentation pertaining to global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests with authoring support from Manufacturing and Quality team members, including amendments to clinical and commercial manufacturing changes
• Responsible for the coordination and management of global submissions, maintenance of product compliance, and management of change control related activities
• Leverage both technical and regulatory knowledge to proactively mitigate risks
• Serves as the Regulatory Affairs CMC representative in cross-functional and team meetings
• Execute regulatory policies and operational processes to deliver high quality regulatory submissions
• Interface with functional areas (Research (preclinical), Clinical, Manufacturing, QA, QC, and Regulatory Operations) to identify and obtain information required for regulatory submissions.
• Assist with preparing/coordinating/filing/managing regulatory applications, annual reports, and information amendments for multiple products.
• Maintain knowledge of current global rules, regulations, and guidance documents governing pharmaceuticals.
• Collaborate in cross-functional teams.
• Assume additional responsibilities as requested.
• Demonstrate flexibility, i.e. willingly take on new tasks.

• Bachelor’s degree in Life Science or Regulatory Science or related field. RAC highly preferred.
• Minimum of 7 years of experience in the biotech/pharmaceutical industry, and a minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company
• Experience in Rare Disease preferred
• Experience leading and developing CMC sections of Biologics marketing applications preferred
• Solid understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends
• Knowledge of EU and international regulations related to clinical and nonclinical, development a plus
• Ability to work independently to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program’s critical regulatory milestones
• Ability to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior management
• Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned with strong attention to detail
• Excellent knowledge of Adobe and MS Office (Word, Excel, PowerPoint.)
• Knowledge of Veeva Vault, and Regulatory Templates preferred.
• Ability to learn new software quickly.

• Strong organization and time management skills, an ability to work on multiple projects simultaneously, and excellent attention to detail.
• Ability to understand and execute on the company’s mission and values.
• Self-organizer, keen attention to detail.
• Highly motivated with excellent interpersonal, collaborative and team-oriented skills to work well with the rest of the organization and build relationships with suppliers.
• Perform other responsibilities to support the needs of the department, as assigned.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Demonstrated ability to work and coordinate with multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.

EOE MFDV