Job Description
Position Summary
MBX Biosciences is seeking a Manager of Regulatory Affairs to join our dynamic team. In this pivotal role, you will support the development and implementation of informed global regulatory strategies, fostering collaboration within a talented, cross-functional project team. Reporting to the Head of Regulatory Affairs, you will provide essential regulatory support for clinical studies, INDs, CTAs and future NDAs. This will include initial filings, amendments and maintenance and managing approvals.
Key Responsibilities
- Actively participate as a member of the Regulatory Affairs team on multidisciplinary project/clinical study teams by providing input on study documentation and procedural requirements as defined by regulatory authorities, including regulatory submission strategy, reviewing of documents, and analysis of procedures used during clinical development.
- Support the preparation and submission of regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.)
- Author, review, contribute and edit submissions to support clinical development including US Investigational New Drug (IND) submissions, Canadian and/or EU Clinical Trial Applications (CTAs), New Drug Application (NDA) and other global submission documents in conformance with regulatory requirements and strategies to ensure high quality and timely submissions.
- Work with business partners, external experts, CROs, and internal colleagues to align on global regulatory strategy and coordinate regulatory submissions.
- Support the multidisciplinary team in preparing responses to regulatory agency questions during the IND and CTA review phases for assigned projects.
- Provide support to prepare project teams for FDA and other regulatory agency meetings, as required.
- Ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across assigned indications.
- Maintain knowledge of global competitive landscape, regulatory environment, regulatory agency regulations and guidelines, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
- Other duties as assigned.
Education & Qualifications
- Bachelor’s, Master’s, PharmD in a scientific, medical, or regulatory discipline with a minimum of 6 years of Regulatory Affairs management experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment is required.
- Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.
- Ability to develop global risk assessment scenarios before functional and team reviews.
- Knowledgeable in ICH and FDA guidelines relevant to device and combination product CMC aspects of product development.
- Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs.
- Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Demonstrated ability to excel in smaller entrepreneurial organizations
Company Overview:
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn.
EEO Statement:
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
