Who We Are…
Novasenta’s mission is to transform medicine by enabling innovative drug discovery at the interface of disease, immunity, and metabolism. Novasenta uses a next generation drug discovery approach combining unique experimental and computational tools to explore the human tumor microenvironment and discover novel therapeutically relevant targets and drugs. We are looking for candidates who have a passion for improving the lives of patients with cancer.
Summary of the Job
The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory Affairs in maintaining Novasenta regulatory submission standards and current electronic submission guidelines/requirements. This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director supports the preparation and submission of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), annual reports, Development Safety Update Reports (DSURs), and safety reports to regulatory authorities.
Job Responsibilities:
- Provide input/recommendation to Regulatory Affairs, Program Management, and Medical Writing Functions on electronic submissions strategies to support IND/CTA applications.
- Manage regulatory operations activities, including preparation of eCTD submission-ready documents, coordination across functions, and adherence to regulatory guidelines and processes.
- Support development program projects by collaborating with multi-disciplinary project teams to ensure successful program deliverables.
- Track and report submission activities, manage processes for archiving health authority correspondence and submissions, and ensure compliance with regulatory standards.
- Support Regulatory team across all aspects of Regulatory Affairs related to the development of novel therapeutics, including nonclinical, clinical, and quality aspects.
- Assist in planning and monitoring of regulatory activities, drafting SOPs and work instructions, and identifying best practices and regulatory precedents.
- Collaborate with internal stakeholders, including preclinical, clinical, CMC, and safety teams, to produce high-quality regulatory submission documents and ensure completion of IND submissions and amendments according to regulatory specifications.
- Assist in the development of Standard Operating Procedures (SOPs), quality assurance, and records management practices related to regulatory operations activities.
- Utilize project management skills to coordinate regulatory activities, establish timelines, and ensure efficient execution of regulatory submissions and deliverables.
- Managing publishing activities including ensuring documents are submission ready, preparation and transfer of final documents, troubleshooting and supporting internal/external team during submission preparation, managing, and completing QC of output, and confirming submission to the health authority.
Job Requirements:
Education & Experience
- Bachelor’s degree in in life/physical sciences or related field; advanced degree preferred; experience in biologics product development preferred
- Minimum of 7 years of experience in regulatory affairs or regulatory operations experience within the pharmaceutical or biotechnology industry.
- Extensive global regulatory experience with INDs/CTAs, BLAs/MAAs, lifecycle management, interactions with Health Authorities and working with project teams
- Experience with assisting with the implementation and maintenance of document management systems.
- A strategic as well as an operational approach with the ability to “think outside the box” and to manage multiple tasks in a fast-paced environment.
- Excellent problem-solving ability and organizational skills, while maintaining attention to detail. A high energy level, a willingness and ability to work in a hands-on capacity, to adapt and respond to a rapidly changing environment, and to work effectively in a project team environment.
- Effective verbal and written communication skills, excellent interpersonal skills, and a team approach.
- The ability to establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines.
- Strong business acumen and ability to make sound decisions that contribute positively to the business.
- Attention to detail and accuracy in document preparation and submission.
Preferred Skills
- Strong written and verbal communication skills
- Self-motivated and able to work independently
- Exceptional time management skills
- Proven team player who can focus on and drive goal completion
What we Offer:
- Highly competitive pay and benefits package.
- Medical/Dental/Vision Insurance
- Annual bonus based on individual and company performance
- Stock Options
- Free parking for those routinely working in the office
- Unlimited PTO
- Retirement Plan with company match
- A dynamic, fast-paced startup culture combined with the stability of a well-established entity (UPMC Enterprises).
- Extensive opportunities for individual growth and professional development.
- Work with experienced leaders in computational sciences, drug discovery, immunotherapy, and cancer fields.