Senior Director Regulatory Affairs

Medella Life; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Medella Life Limited is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy for a developing clinical pipeline. The role reports to executive leadership and collaborates with Clinical Development, CMC, Quality and Medical Affairs to drive regulatory success.

You will oversee IND, NDA and BLA submissions, interact with FDA/EMA, and guide regulatory planning across all stages of development from early trials to commercialization.

Qualifications

• 10+ years in regulatory affairs within pharma/biotech.
• Experience at Director/Senior Director level or equivalent.
• Strong experience developing US regulatory strategies.
• Proven FDA submissions experience (INDs, NDAs, BLAs).
• Experience leading regulatory activities across multiple development stages.
• Excellent communication with senior stakeholders.

Responsibilities

• Lead development and execution of global regulatory strategies across the pipeline.
• Provide regulatory leadership for IND, NDA and BLA submissions, including preparation and management.
• Oversee interactions with FDA, EMA and other health authorities.
• Guide regulatory strategy through Phase I-III development.
• Provide regulatory guidance on trial design and development plans.
• Oversee submissions, amendments, annual reports and agency correspondence.
• Partner with CMC, Clinical Operations, Nonclinical and Quality teams for alignment.
• Represent Regulatory Affairs in senior leadership meetings and advise on strategies.
• Build and maintain relationships with regulatory agencies and consultants.
• Identify risks and mitigate impacts on timelines.
• Support growth and expansion of Regulatory Affairs function.

Skills

FDA submissions

Regulatory leadership

IND/NDA/BLA

Cross-functional

Strategic planning

ICH guidelines

Executive communication

Job description

We are working with an innovative, growing biotechnology company seeking an experienced Senior Director of Regulatory Affairs to lead and oversee its global regulatory strategy across a developing clinical pipeline.

This is a senior leadership opportunity for an established regulatory professional with experience developing and executing regulatory strategies across all stages of drug development, from early-stage clinical programmes through to late-stage development and commercialisation.

The successful candidate will work closely with Clinical Development, CMC, Quality, Medical Affairs and executive leadership, acting as a key regulatory advisor to the wider business.

Key Responsibilities

• Lead the development and execution of global regulatory strategies across the company's pharmaceutical pipeline.
• Provide regulatory leadership across IND, NDA and BLA submissions, including preparation, review and submission management.
• Oversee regulatory interactions and negotiations with the FDA, EMA and other international health authorities.
• Lead regulatory strategy throughout clinical development, including Phase I-III programmes.
• Provide strategic regulatory guidance on clinical trial design, development plans and product registration pathways.
• Oversee regulatory submissions, amendments, annual reports, briefing documents and agency correspondence.
• Partner with CMC, Clinical Operations, Nonclinical and Quality teams to ensure regulatory alignment throughout development.
• Represent Regulatory Affairs in senior leadership meetings and provide recommendations on development and commercialisation strategies.
• Build and maintain relationships with regulatory agencies and external regulatory consultants.
• Identify regulatory risks, assess potential impact on development timelines and implement mitigation strategies.
• Support the development and expansion of the Regulatory Affairs function as the organisation grows.

Required Experience

• 10+ years of pharmaceutical or biotechnology industry experience within Regulatory Affairs.
• Previous experience operating at Director, Senior Director or equivalent regulatory leadership level.
• Strong experience developing and executing US regulatory strategies.
• Proven experience with FDA submissions, particularly INDs, NDAs and/or BLAs.
• Experience leading regulatory activities across multiple stages of drug development.
• Demonstrated experience managing FDA meetings, including pre-IND, End-of-Phase II and pre-NDA/BLA interactions.
• Strong understanding of FDA regulations, ICH guidelines and global regulatory requirements.
• Experience working cross-functionally within small or mid-sized biotech/pharmaceutical organisations.
• Excellent communication skills with the ability to influence senior stakeholders and executive leadership.

Preferred Experience

• Experience within oncology, rare disease or other specialist therapeutic areas.
• Previous experience supporting a company through significant clinical and regulatory milestones.
• Experience with global regulatory submissions and EMA interactions.
• Experience working within lean, high-growth biotechnology environments.
• Previous involvement in NDA/BLA approvals and commercial product launches.