Director, Regulatory Affairs - Global Regulatory Lead

Reporting to the SVP, Head of Regulatory Affairs, the Director, Regulatory Affairs – Global Regulatory Lead will serve as the primary global regulatory strategist for assigned products across all phases of development and commercialization. This individual will be responsible for developing and implementing global regulatory strategies, leading interactions with health authorities, and ensuring compliance with applicable regulatory requirements to support successful product approvals and lifecycle management.

Please note this is a full-time onsite opportunity

Responsibilities: 

• Regulatory Strategy & Leadership
• Serve as the Global Regulatory Lead (GRL) on cross-functional product development teams.
• Develop and execute global regulatory strategies for assigned pipeline and future marketed products.
• Provide strategic input into clinical development programs, labeling, CMC, and nonclinical plans to optimize regulatory outcomes.
• Anticipate and assess regulatory risks; propose and implement mitigation strategies.
• Health Authority Interactions
• Lead preparation and execution of global regulatory agency interactions (e.g., FDA, EMA, MHRA, and other agencies worldwide).
• Oversee preparation of briefing packages, regulatory responses, and key regulatory submissions (e.g., IND/CTA, NDA/BLA/MAA, supplements, variations).
• Submissions & Compliance
• Ensure timely preparation, review, and submission of high-quality regulatory documents to support global development and registration.
• Partner with CMC, Clinical, and other functions to ensure regulatory requirements are met across regions.
• Monitor evolving global regulations and provide guidance on implications to the product portfolio.
• Oversee and/or personally execute Regulatory Operations responsibilities, including dossier preparation, QC, publishing and proper archiving of submissions, Health Authority correspondence, and commitments.
• Cross-Functional Collaboration
• Act as the regulatory point of contact to cross-functional development teams, senior management, CROs, and alliance partners.
• Provide regulatory guidance during due diligence and business development activities, as needed.
• Gather regulatory intelligence and seek opportunities to influence external regulatory environment and health policy through collaborations with industry groups and providing company positions on guidance and policy documents.

Qualifications:

• Advanced degree in Life Sciences, Pharmacy, or related field (Ph.D., Pharm.D. preferred).
• Minimum of 10 years of progressively responsible experience in the biopharmaceutical industry R&D departments with at least 6 years of direct regulatory experience.
• Experience across all stages of drug development from First in Human to pivotal studies and through commercialization. Experience with siRNA or ASO modalities is a plus.
• Proven track record as a Global Regulatory Lead with successful health authority interactions and approvals (IND/CTA, NDA/BLA/MAA).
• Strong understanding of global drug development processes, regulations, and guidelines.
• Demonstrated leadership in developing regulatory strategy in alignment with business objectives.
• Experience operating in a small or start-up biotech environment, with a hands-on and collaborative approach.
• Excellent interpersonal, communication, and influencing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to anticipate and address regulatory challenges proactively.

Competencies:

• Strong scientific background and ability to rapidly develop working knowledge of the scientific issues underlying assigned product’s development (pharmacology, toxicology, clinical, safety, and CMC).
• Strategic thinker with ability to balance risk and opportunity.
• Hands-on, resourceful, results-oriented individual who is ready to roll up their sleeves and get the job done despite resource constraints or timeline pressures.
• Strong organizational and project management skills.
• Collaborative leader, adept at building relationships across cultures and geographies.

City Therapeutics is accepting resumes/CVs from direct applicants only.  Recruitment Agency inquiries or submissions will not be accepted at this time.

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.