Job Description
GENERAL INFORMATION
Position Title:
Director/Senior Director of Regulatory Affairs
Department:
Regulatory
Reports to:
VP of Clinical Development
Purpose of the job
Rani Therapeutics is seeking an experienced and hands-on Regulatory Affairs leader to develop, lead and execute the company’s regulatory strategy across drug, device, and combination product pathways. As the sole regulatory professional at the company, this individual will personally author submissions, manage agency interactions, and build regulatory infrastructure from scratch, while also serving as the external face of Rani’s regulatory strategy with partners, investors, and health authorities. This individual will play a critical role in guiding the company through IND submissions, regulatory interactions with FDA and global health authorities, responding to FDA / global health authorities feedback and inquiries, and strategic engagements with partners, investors, and government agencies.
The ideal candidate thrives in a fast-paced environment, has demonstrated success in early-stage companies, and brings deep experience navigating complex regulatory frameworks spanning pharmaceuticals, medical devices, and combination products.
Major Duties And Responsibilities
Regulatory Strategy & Leadership
- Develop, lead, and execute the regulatory strategy for Rani’s pipeline programs.
- Serve as Rani’s regulatory strategist for Rani’s partnered programs.
- Define and execute regulatory pathways for IND submissions, product development, and registration.
- Provide clear regulatory expertise to executive leadership, R&D, Quality, Manufacturing, Preclinical and Clinical teams.
- Serve as a strategic thought partner to the CEO and executive team on regulatory risk, timelines, and trade-offs.
Regulatory Submissions & Agency Engagement
- Personally lead and author preparation, review, and submission of INDs, meeting packages, and regulatory correspondence.
- Act as the primary regulatory representative with FDA (CDER, CBER, CDRH, OCP) and other global health authorities as needed.
- Plan and lead regulatory meetings (Pre-IND, Type B/C, scientific advice, etc.).
- Ensure alignment across drug and device regulatory expectations for combination products.
- Advise partner on regulatory interactions for partner-led programs to ensure consistency of positioning with FDA / global regulatory authorities
Cross-Functional Collaboration
- Partner closely with Preclinical, Clinical, CMC, Quality, Manufacturing, Engineering, and R&D to ensure regulatory requirements are embedded early and effectively.
- Provide regulatory input into development plans, protocols, risk assessments, and technical documentation.
- Support Quality and Manufacturing teams on regulatory compliance, inspections, and readiness activities.
- In the absence of a regulatory team, act as the connective tissue across all functions owning regulatory deliverables end-to-end.
External Representation & Stakeholder Engagement
- Represent Rani Therapeutics with partners, collaborators, investors, and external stakeholders, clearly articulating regulatory strategy and risk mitigation.
- Support due diligence activities, partnering discussions, and investor communications from a regulatory perspective.
- Manage external consultants, CROs, and regulatory vendors as needed.
Hands-On Execution & Operational Build-Out
- Establish scalable regulatory processes, systems, and best practices appropriate for a growing public biotech company— building these from the ground up.
- Balance strategic leadership with a roll-up-your-sleeves mentality, personally contributing to critical deliverables when needed.
- Operate effectively as a department of one, managing priorities, timelines, and deliverables with minimal administrative support.
Leadership Attributes
- Strategic thinker and doer with strong execution skills
- Collaborative, pragmatic, and solutions-oriented
- Comfortable making decisions with incomplete information
- High integrity, sound judgment, and strong regulatory ethics
- Entrepreneurial mindset with a passion for innovation
- High emotional intelligence with demonstrated ability to productively partner across functions and diverse personality types
- Comfortable being the only regulatory professional in the room — internally and externally
Education And/or Job Experience
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related field required (PhD, PharmD, MD preferred).
- 15+ years of regulatory affairs experience in biopharma, medical devices, or combination products, including leadership roles with a strong preference for combination experience.
- Demonstrated experience leading IND submissions and regulatory interactions with the FDA.
- Strong knowledge of FDA, EMA, and other global regulatory agency guidelines
- Strong understanding of drug, device, and combination product regulatory frameworks, including FDA Office of Combination Products.
- Experience working in startup or high-growth biotech environments, with comfort operating in ambiguity.
Skills And Specifications
- Proven ability to personally execute regulatory strategy — drafting INDs, authoring regulatory documents, and managing agency interactions without reliance on a supporting team. Strong analytical and problem-solving skills
- Excellent written and verbal communication skills with the ability to represent the company externally and influence executive leadership, partners, and external stakeholders.
- Attention to detail and organization skills
- Prior experience supporting programs through early clinical development.
- Experience in oral delivery systems, biologics, or innovative drug delivery technologies is a plus.
- Experience with regulatory submission processes and interacting with global regulatory authorities (FDA, EMA, MHRA, etc.).
- Experience supporting public-company regulatory expectations and disclosures.