Job Description: Director, Regulatory Affairs
Proteostasis Therapeutics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of novel therapeutics that treat diseases caused by an imbalance in the proteostasis network, a set of pathways that control protein biosynthesis, folding, trafficking and clearance. Our initial therapeutic focus is on cystic fibrosis, or CF, which is caused by defects in the cystic fibrosis transmembrane conductance regulator, or CFTR, protein and insufficient CFTR protein function. CF is an orphan disease that affects an estimated 70,000 to 100,000 patients worldwide, with the vast majority of affected individuals in the United States, Canada, Europe and Australia. CF is the most common fatal inherited disease in Caucasians, and there is presently no cure.
Our founders and scientific advisory board members include many of the world’s foremost proteostasis network experts and serve as an ongoing resource to complement our internal team’s core competencies. Leveraging our unique and comprehensive expertise of the proteostasis network, we have developed the Disease Relevant Translation, or DRT, technology platform, a validated drug screening approach for identifying highly translatable therapeutics based on predictive and functionally pertinent phenotypic assays and disease relevant models. Using this proprietary platform, we identified a new class of small molecules, which we call amplifiers that modulate proteins in the proteostasis network.
Position Title: Director, Regulatory Affairs
The Director, Regulatory Affairs will be responsible for developing and implementing regulatory strategies as well as coordinating all aspects of regulatory submissions. This person will represent the function of Regulatory Affairs and lead the regulatory strategy on project teams.
Duties & Responsibilities:
- Develop and implement regulatory strategies for all products in development.
- Ensure efficient execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) worldwide
- Lead activities, including planning, writing and reviewing, as well as responses to regulatory agencies, of all regulatory submissions (INDs, CTAs, meeting requests, and briefing documents) to support clinical trials and project milestones.
- Be responsible for Regulatory Intelligence for relevant disease area and to identify and then communicate the implication of upcoming trends that may impact the business.
- Be responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities which has the potential to impact strategy
- Have knowledge of current global regulations and guidelines
- Review Clinical, Nonclinical, and CMC documentation to ensure compliance with regulatory requirements.
- Work effectively on cross-functional teams and be the primary regulatory representative at internal meetings as well as at meetings with regulatory agencies and external contract organizations.
- Guide project teams in planning and requirements for future commercial filings (NDA/MAA) and assess regulatory impact for development process changes.
- Monitor and effectively manage regulatory project timelines and budgets
- Lead junior level regulatory employees
- Other duties and ad hoc projects as assigned.
- 7-10 years of industry experience in pharmaceutical product development, with a minimum of 5 years in Regulatory Affairs.
- Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulations in all regions.
- Experience in rare/orphan disease desirable
- Combination product development experience preferred
- Pediatric development experience is desirable
- Excellent written and oral communication and interpersonal skills.
- Solid knowledge of overall drug development and in-depth knowledge of FDA and EMA regulatory requirements.
- Works well in a high-achieving team based environment.
- Sense of urgency is a must.
- Previous direct experience in leading development and/or marketing authorization submission teams and in interacting with regulatory authorities.
** To comply with regulations by the American with Disabilities Act (ADA), the principal duties in job descriptions must be essential to the job. To identify essential functions, focus on the purpose and the result of the duties rather than the manner in which they are performed. The following definition applies: a job function is essential if removal of that function would fundamentally change the job.
Applicants should send a resume and cover letter to: Director of Human Resources at firstname.lastname@example.org