GENERAL ROLE DESCRIPTION:

This position focuses on the management of clinical, nonclinical and CMC aspects of domestic

regulatory affairs for a gene therapy product. The role involves working closely with in-house clinical, pre-clinical and CMC teams, partners, contract research organizations, and global health authorities to ensure rapid review and approval of INDs, clinical trial applications and other clinical-oriented filings. The candidate will lead interactions with regulatory agencies, provide insight and regulatory strategies. Expertise with gene therapy or biologics is strongly preferred. This position is also responsible for obtaining and interpreting regulations and guidance and providing regulatory advice to clinical and pharmacology/toxicology departments. Strong communication and management skills are required.

PRIMARY RESPONSIBILITIES:

• Establish the long-term strategy for the regulatory team and regulatory activities for the assigned programs, in collaboration with cross-functional teams.
• Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and responses to agency correspondence.
• Oversee planning, preparation, and submission of the regulatory documents (protocols, investigator brochures, CMC and nonclinical sections of INDs, briefing documents, etc) globally. Ensure that the documents are complete, well-written, and meet all relevant requirements.
• Develop excellent relationships with internal functional groups, contract research organizations, and partners.
• Coordinate and lead responses to health authority questions/inquiries as needed to meet project milestones. Manage interactions with FDA or other regulatory authorities for assigned projects.
• Provide regulatory advice to clinical teams, CMC and pharmacology/toxicology departments based on knowledge of current requirements.
• Review local and global regulations and apply interpretative analyses of key regulatory guidance documents as they relate to ongoing projects and submissions.

QUALIFICATIONS:

Education & Experience:

• Sc. degree minimum. Advanced degree a plus.

Experience:

• At least 8 years of experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to the development phase of the product lifecycle)
• Experience in filing INDs and CTAs
• Experience with gene therapy or biologic products is preferred.
• Thorough understanding of relevant drug development regulations and guidelines
• Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs

Skills:

• Ability to develop timelines, plan regulatory submissions and work with cross-functional teams to develop content.
• Ability to prepare and submit regulatory documents with strong attention to detail
• Ability to multi-task and support more than one project simultaneously
• Highly organized and motivated; strong analytical, organizational, and problem-solving skills
• Strong work ethic, flexibility, and cooperative can-do attitude
• Ability to work cooperatively in a team-based environment; supportive of multiple viewpoints and approaches
• Strong communication skills (both written and oral) with demonstrated ability to present ideas, information and data effectively via one on one discussions, team meetings, and external partnership interactions
• Understanding and knowledge of key software programs (including Microsoft Word, Adobe PDF).

Base salary compensation range:

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.