What are the responsibilities and job description for the Regulatory Manager position at Boston Pharmaceuticals?
Company Overview:
Boston Pharmaceuticals is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in severe liver diseases, with MASH as the focus of its lead asset. The Company has significant expansion opportunities through its portfolio of promising drug development candidates that were acquired through partnerships with proven, innovative biotechnology and pharmaceutical companies. Boston Pharmaceuticals applies rigorous decision-making to advance programs to deliver differentiated medicines to patients in need of new options while creating value for all parties involved in the journey.
Position Summary:
The Regulatory Manager will be responsible for regulatory operational activities and, in collaboration with members of the Regulatory team, developing, driving, and implementing global regulatory strategies for Boston Pharmaceuticals’ products. This individual will be a core member of the regulatory team and will also support program teams with respect to regulatory aspects necessary to evaluate clinical options, enable plans, and optimize development programs. Additionally, this individual will have an understanding of relevant development and scientific issues and take a data-driven approach to drug regulatory affairs.
Roles & Responsibilities:
- In collaboration with the Regulatory team, design, implement, drive, and monitor global Regulatory strategies to inform Boston Pharmaceuticals’ programs
- Liaise with internal teams and external partners to execute program objectives. This includes the evaluation of regulatory risks/gaps and developing contingency plans with a focus on efficient global planning for Boston Pharmaceuticals’ products..
- Provide regulatory operational support to program teams.
Qualifications:
- Bachelor’s or higher in pharmaceutical sciences or related field required; advanced degree preferred
- Experience (5-8 years) in the biopharma industry in a Regulatory role, with proven ability to represent Regulatory Affairs on project teams and/or in Health Authority interactions
- Must have experience in drug development, particularly in late-phase drug development (phase 3 and beyond)
- Demonstrated leadership in preparing, managing, and submitting regulatory filings, including INDs, CTAs, NDAs, BLAs, and MAAs, including effective communication with internal and external stakeholders and effective project management.
- Strong expertise in U.S. (FDA) and European (EMA) regulations; experience with Asia-Pacific (e.g., PMDA, NMPA) is preferred.
- Hand-on experience with various submission and review systems and EU submission portals for various submission types.
- Experience with expedited pathways such as Fast Track, Breakthrough Therapy, and PRIME designations preferred.
- Experience with pediatric investigation plan and pediatric study plans.
- Excellent communication and organizational skills
- Strong attention to detail and process oriented
- Strong time management skills; ability to prioritize multiple tasks efficiently
- Resourceful and flexible: manage multiple and changing priorities in a dynamic environment
- Ability to think creatively and independently, and to proactively manage regulatory risk
- Ability to collaborate with teams to achieve goals and objectives.
- Track record of providing scientifically informed regulatory advice which includes strategic options and associated risks.
- Embraces and embodies Boston Pharmaceuticals’ corporate values: Commitment to Patients, Decisive Innovation, Purposeful Urgency, Passion for Excellence, One Team