Chiasma is a late stage Phase 3 biopharmaceutical company focused on improving the lives of patients suffering from orphan diseases by developing and commercializing novel oral forms of therapies that are available today only by injection. The company’s lead product candidate is octreotide capsules for the orphan condition acromegaly and is currently in Phase 3 multinational clinical studies designed for both FDA and EMA commercial approval. Chiasma is a well-funded, public Delaware corporation (Nasdaq: CHMA) with wholly owned Israeli subsidiary.
Reporting to the Chief Executive Officer (CEO), The Head of Regulatory will be accountable for driving the regulatory strategy in collaboration with the senior management team and will be responsible for driving timely regulatory submissions and approach. This will include US and Global Regulatory Submissions, approaches to regulatory pathways and labeling. The Head of Regulatory will advise management on regulatory agencies with the CEO on behalf of Chiasma.
This position involves both high level strategic planning, interpersonal interactions with regulators, partners as well as hands-on responsibilities.
- Develop US and global regulatory strategy aligned with Chiasma’s business objectives
- Develop regulatory approaches, frameworks and pathways
- Execute on the Chiasma regulatory strategy and activities
- Provide guidance, direction and leadership on that strategy to the development to the development team and senior management
- Build a global regulatory team that provides input into development, medical, and commercial teams
- Provide strategic input to clinical development plans
- Maintain up-to-date knowledge of US laws, regulations and guidelines as well as familiarity with the global regulatory environment
- Act as primary liaison with all regulatory authorities via regulatory correspondence and leading regulatory meetings
- Identify and coordinate with regulatory and experts and consultants
- Author, review and edit regulatory submissions
- Provide project plans and timelines for regulatory submissions
- Drive timelines and deliverables related to submission documents
- Understand electronic submission process and guide the development team in the preparation of electronic regulatory submissions and build the organizational infrastructure as needed
- Author, and/or review edit documents i.e. informed consents, Investigator Brochures, study materials, essential documents, presentations, and reports as necessary
- Advanced degree with a minimum of 15 years of industry experience and 8-10 years of direct experience as well as 5 years of experience in a senior regulatory role
- Experience in the Endocrinology space preferred
- Extensive experience understanding FDA guidance, new regulations/standards and submission of products for FDA review
- Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development
- Experience with orphan indications, breakthrough, and novel regulatory pathways to for an approval essential
- Demonstrated leadership competencies in establishing clear direction and objectives, ability to simplify complex processes and foster an environment that brings out the best in people
- Strong strategic and analytical abilities
- Excellent verbal and communication skills
Chiasma Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.