[Cambridge, MA] Head of Regulatory Affairs
BIORCHESTRA is an innovative biotech company focusing on research and development of ribonucleic acid (RNA) based therapeutics. Our goal is to change the therapeutic paradigm from treating the symptoms to modifying the progression of the disease process.
As we are making steady progress towards selecting our lead clinical candidate, we are looking for an exceptional candidate as Head of Regulatory Affairs to define our regulatory strategy and to lead our communications and filings with the major national and International regulatory agencies.
Based in Daejeon, South Korea, and Cambridge, MA, BIORCHESTRA has identified a novel pathway of neuroinflammation involved in neurodegenerative diseases and has developed proprietary drugs and targeting formulations that allow delivery to the brain
through systemic administration.
Head of Regulatory Affairs
This position will be based in Cambridge, MA, and will report to the Chief Medical Officer of the Company.
The successful candidate will have senior-level and international experience in Regulatory Affairs and will have led meetings and major filings in the leading regulatory regions.
The candidate will provide strategic and operational leadership for BIORCHESTRA’s regulatory activities and will ensure regulatory activities are well-prepared, compliant, timely and successful.
The candidate will provide guidance to and ensure close collaboration with BIORCHESTRA’s Research, Pharm/Tox, Clinical, and Manufacturing
teams, and external partners, to successfully execute on all aspects of the Company’s regulatory commitments.
The candidate will build and manage the regulatory team and ensure that its activities are governed by an appropriate Quality
System for Regulatory Affairs. The candidate will also monitor global regulatory requirements and trends to ensure the Company adjusts appropriately to changing national and international requirements.
- Provide expert advice to senior management on regulatory strategies, opportunities, and risks in support of the stated goals of the
- Develop and lead the optimal regulatory strategy for each drug candidate in the product pipeline in accordance with relevant therapeutic
area or product guidances
- Serve as primary liaison with regulatory authorities, including overseeing the writing of pre-meeting briefing materials, leading the
preparation for and facilitating sponsor interactions at regulatory meetings, and ensuring appropriate minutes and follow-up.
- Responsible for planning, authoring, and executing of regulatory document filings including INDs/CTAs, NDAs/CTDs/MAA, and others
- Serve as primary regulatory representative for the Company’s cross-functional teams and for external partnership steering committees
- Build and manage a high-performing Regulatory Affairs team, ensuring that internal expertise reflects the diverse needs of the Company
by platform, product, function, and geography
- Maintain regulatory expertise on and knowledge of relevant global regulations and guidelines, and of regulatory precedents
- Ensure effective department procedures, including creating, enacting, and maintaining relevant SOPs, including inspection readiness
- Provide regulatory due diligence and regulatory advice for potential new product and partnering opportunities
- Provide and manage budgets, timelines, and resources estimate for program planning
Job Requirements include:
- PhD, or PharmD Ph.D. in a relevant field of study
- 15+ years of experience in Regulatory Affairs in the pharmaceutical/biotech industry or contract research organization (CRO)
- Experience in major Regulatory filings such as NDAs or MAAs, and their appprovals, is required
- Experience in CMC Regulatory Affairs is highly valued
- Experience in CNS-active or oligonucleotide drugs is preferred
- Experience in successful regulatory negotiations, resolution of complex regulatory issues, and regulatory inspections is also highly
- Evidence of broad-based experience in collaborating across multiple functions and with company management
- Ability to work across cultures, time zones and languages
- A focus on Quality Management
- Excellent writing and verbal
- communication skills, fluent in English
BIORCHESTRA is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by
Please submit your CV and Resume to email@example.com