The Director, Regulatory Affairs reports to the VP, Regulatory Affairs and executes clinical and preclinical regulatory strategies and activities. This includes implementation of global regulatory strategies, ensuring timely preparation, review, and submission of clinical and preclinical documents to regulatory authorities, collaboration with clinical and nonclinical partners with a regulatory strategic focus, and maintaining compliance with applicable regulatory requirements.

This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.

• Implement the overall clinical and nonclinical global regulatory strategy across the product lifecycle towards initial approval, launch, and label expansions.
• Develop and maintain a product-specific global regulatory plan
• Collaborate with within regulatory and cross functional teams, including clinical development, clinical operations, translational research, safety, and medical affairs to develop and manage specific product development plans.
• Provide regulatory input and guidance to the clinical and nonclinical development plans.
• Ensure consistent application of the clinical regulatory strategy through consultation and review of clinical study protocols, statistical analysis plans, and study reports.
• Identify and implement regulatory initiatives (i.e., Orphan Drug Designation, Breakthrough Designation, etc.) to facilitate and expedite patient access to the product.
• Coordinate and ensure timely preparation, review, and submission of clinical and nonclinical documentation packages for regulatory agency interactions (e.g., FDA pre-/BLA, EOP2 meetings, advisory committee meetings and/or UK and EU oral explanations/scientific advice, etc.)
• Ensure consistent interpretation of the regulatory strategy during the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
• Develop the strategy and plan for an accepted investigation in pediatric patients in compliance with both EMA, UK, and FDA.
• Develop submission plans and timelines for clinical and nonclinical sections in partnership with CMC regulatory SMEs for coordination with CMC sections.
• Triage, coordinate and manage responses to questions from regulatory authorities by collaborating with the clinical teams to address regulatory agency feedback.
• Manage and mentor resources for the authoring and preparation of clinical and nonclinical sections as applicable.
• Influence strategy to address internal or external business and regulatory issues and proactively identify potential strategic issues and opportunities.
• Identify, assess, and communicate potential risks associated with development and regulatory strategy scenarios and plan risk mitigation strategies.
• Partner with commercial team and labeling SME to develop and maintain the target product profile and target product label.
• Monitor agency meetings, workshops, and publications to maintain company awareness of evolving regulatory landscape.
• Perform ad hoc research on specific regulatory topics to support product development.

• Contribute to initiatives to improve processes within the Regulatory department.
• Research and analyze global regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and upcoming changes.
• Review SOPs and protocols with regard to regulatory matters.
• Performs other appropriate administrative duties, such as preparing correspondence and filing, where necessary
• Maintains regulatory documentation including submissions to and correspondence with each governing authority.
• Provide mentoring to staff and have skill sets for directly managing staff.
• Manage external regulatory consultants and project deadlines, as needed.

• A or B.S. degree, MS preferred, in an appropriate scientific field with 10+ years’ experience in Pharmaceutical/Biotech Industry with 5+ years in a Clinical Regulatory Affairs, capacity.

• Professional knowledge and skills working with solid tumor oncology therapeutics is required with biologic, gene therapy or vaccine experience preferred.
• Team player with confidence, coupled with excellent written and verbal communication skills as well as outstanding analytical abilities but with a willingness to be hands on and does not delegate responsibilities.
• Previous experience in representing the sponsor in front of regulatory agencies and as primary regulatory author for regulatory submission documents in preparing successful regulatory submissions (BLA, MAA, IND, CTA, etc.) to the global regulatory authorities.
• Expedited approval pathway, rare disease, and commercial experience preferred.
• Highly knowledgeable in ICH, FDA and EMA regulations and guidelines and experience working in a global environment.
• Skilled in multiple computer-based tools, in addition to software programs such as MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio
• Strong interpersonal, organizational, and time management skills with attention to detail
• Ability to problem-solve and maintain composure in difficult situations.
• Ability to work independently and manage multiple projects in a fast-paced environment.
• Capable of handling matters of strict confidentiality and sensitivity.
• Appropriate GCP or GXP training
• Experience with the development and support of related SOPs and policies is expected.
• Ability to relate and work with a wide range of people to achieve results.
• Successful and superior influencing skills across all levels of the organization and with external collaborators.
• Problem solving and risk-mitigation skills.
• Ability to build working relations throughout the organization and with business partners to achieve business goals.
• Ability to travel approximately 10% of time.

This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.