Senior/Director - Regulatory Affairs

About the job Senior/Director - Regulatory Affairs


Director / Senior Director, Regulatory Affairs

About the Role

The company is seeking a Director or Senior Director of Regulatory Affairs - with the final title set according to the selected candidate's background - to help shape and steer the execution of worldwide regulatory strategy across assigned programs, keeping all work consistent with applicable national and regional requirements as well as internal policy. The person in this role acts as the principal Regulatory Affairs voice on global program teams across the window running from shortly before Phase 1 through the close of Phase 3. They will drive clear communication and close coordination among collaborators inside and outside the organization, and with health authorities around the world. Core duties include supervising regulatory CRO work; organizing and leading engagements with health authorities; and assembling and filing high-caliber INDs, CTAs, BLAs/MAAs, meeting packages, responses to information requests, and amendments, along with mandatory deliverables such as safety reports and annual filings. This is a fully onsite position.

Responsibilities

• Supply strategic regulatory guidance for global drug development efforts, covering areas such as regulatory requirements, avenues for expedited development, and the timing and content of agency engagements that advance program success.
• Direct the assembly of regulatory filings, overseeing the planning, coordination, drafting, and review of every submission sent to health authorities worldwide - including INDs, CTAs, BLAs, MAAs, amendments, replies to questions and information requests, safety reports, and annual updates/DSURs for assigned projects.
• Translate regulatory expectations for stakeholders and convey them clearly so program goals are achieved in keeping with applicable rules.
• Stay current on and apply a thorough grasp of pertinent regulations and guidance in order to improve the likelihood of regulatory success and sustain compliance.
• Confirm that regulatory outputs back the goals and timelines set by the company and its project teams.
• Contribute risk-reduction development approaches and weigh opportunities to speed development within a rapidly moving setting.
• Serve as the Regulatory Affairs representative on worldwide project teams, sub-teams, and external partnerships.
• Oversee regulatory personnel at the CRO conducting clinical trials.
• Support clinical study activities, including engaging with CROs as needed.
• Build and roll out data management approaches that align with company goals.
• Operate as part of a team while cultivating productive relationships with colleagues inside and outside the organization.

Qualifications

• A bachelor's degree in a clinical, scientific, medical, or related field is required; a graduate degree (MS, PharmD, PhD) is preferred.
• A minimum of 8 years working as a regulatory professional within the bio/pharmaceutical sector, including a track record of direct, successful dealings with regulatory agencies.
• Demonstrated success delivering regulatory submissions across the US and Europe, spanning major filings (for example, IND, CTA, BLA, NDA) and the maintenance of active programs (for example, annual reports and safety reporting).
• Strong command of FDA, European agency, and ICH regulations and guidance, plus the ability to determine regulatory requirements in additional jurisdictions.
• Understanding of drug development and the regulatory dimensions of clinical study design, biostatistics, and pharmacokinetics.
• Sound judgment about when and how to escalate and communicate potential or actual issues to management.
• A history of collaborating effectively with cross-functional project teams.
• Strong writing and speaking ability, with a talent for conveying regulatory positions clearly to varied audiences.
• Strong interpersonal abilities.
• Proficiency formatting documents in MS Word.
• Capacity to work autonomously in a fast-changing drug development environment.
• Skilled at juggling multiple priorities, ordering tasks, and meeting deadlines.
• Strong project management capabilities and a drive for high-quality work.

Preferred Qualifications

• Prior experience at a biotechnology company.
• Knowledge of the regulatory aspects of biologics manufacturing, including past responsibility for and oversight of submissions containing CMC documentation.
• Background in drug development for inflammatory bowel disease.
• A scientific grounding in immunology, cell biology, and preclinical assays.
• Experience preparing documents so they meet the requirements of regulatory submission gateways.
• Exposure to both early- and late-stage drug development.
• Recent involvement with BLA, NDA, and MAA filings.
• Familiarity with EU-CTR, IVDR, and the FDA NextGen Portal.