Company Overview:
Inozyme Pharma,Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical companydeveloping novel therapeutics for the treatment of diseases of abnormalmineralization impacting the vasculature, soft tissue, and skeleton. Throughour in-depth understanding of the biological pathways involved inmineralization, we are pursuing the development of therapeutics to address theunderlying causes of these debilitating diseases. It is well established thattwo genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathwayand that defects in these genes lead to abnormal mineralization. We areinitially focused on developing a novel therapy, INZ-701, to treat the raregenetic diseases of ENPP1 and ABCC6Deficiencies. INZ-701 is currently in Phase1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency.
Position Overview:
As the Senior Manager/Associate Director ofRegulatory Strategy, you will play a critical role in driving the developmentand execution of regulatory strategies for our rare disease therapeuticprograms. Your expertise and leadership will be instrumental in navigating thecomplex regulatory landscape and ensuring compliance with regulatoryrequirements.
You will develop and implement US regulatorydevelopment strategy leading to successful registration and life-cyclemanagement of unique and technologically complex products serving patients withrare diseases and unmet medical needs. You will collaborate closely withcross-functional teams, including Clinical Development, Medical Affairs,Quality Assurance, and Commercial, to achieve regulatory milestones and supportsuccessful product development and commercialization.
Responsibilities:
Provides support to regulatory affairsreviewers for due diligence initiatives, including opportunity and riskassessment.
1. Develop and implement globalregulatory strategies for rare disease therapeutic programs, ensuring alignmentwith corporate objectives and regulatory requirements.
2. Accountable for preparation andexecution of regional aspects of the regulatory global strategy. Can includesetting direction for junior staff to execute regional regulatory tasksaccording to strategy.
3. Provide strategic guidance andleadership to cross-functional teams on regulatory requirements, agencyinteractions, and submission strategies throughout the product lifecycle.
4. Lead the preparation, review, andsubmission of high-quality regulatory documents, including INDs, BLAs, NDAs,and other relevant filings, ensuring compliance with applicable regulations andguidelines.
5. Monitors the development of newregulatory requirements or guidance documents and advises product teams of theimpact on the business or development programs
6. Proactively monitor and analyzeregulatory trends, guidelines, and developments related to rare diseasetherapies, and provide strategic recommendations to senior management.
7. Serve as the primary point of contactfor regulatory agencies (FDA, EMA, etc.), representing the company ininteractions, meetings, and negotiations.
8. Collaborate with cross-functionalteams to develop and execute regulatory communication plans, includingscientific advice meetings, pre-submission meetings, and regulatory authorityinteractions.
9. Build and maintain effectiverelationships with key stakeholders, including regulatory agencies, key opinionleaders, and external consultants.
10. Stay current with evolving regulatoryrequirements and best practices, and ensure compliance with all applicableregulations, guidelines, and industry standards.
11. Provide regulatory guidance andsupport to internal teams to ensure compliance with regulatory obligationsthroughout the organization.
12. Mentor and develop regulatory teammembers, fostering a culture of excellence, collaboration, and continuouslearning.
Qualifications:
1. Advanced degree (Ph.D., Pharm.D., orequivalent) in life sciences or a related field.
2. Minimum of 6 years of regulatoryaffairs experience in the biopharmaceutical industry, with a focus on rarediseases and orphan drug development.
3. Strong knowledge of global regulatoryrequirements and guidelines for drug development and registration, includingFDA and EMA regulations.
4. Proven track record of successfullyleading regulatory strategy and submissions for rare disease therapeuticprograms.
5. Experience with regulatoryinteractions, including FDA meetings (pre-IND, end-of-Phase 2, pre-NDA, etc.)and EMA scientific advice procedures.
6. Demonstrated ability to providestrategic regulatory guidance and effectively communicate complex regulatoryinformation to cross-functional teams and senior management.
7. Strong leadership and peoplemanagement skills, with the ability to motivate and develop high-performanceteams.
8. Excellent written and verbalcommunication skills, with the ability to influence and negotiate with internaland external stakeholders.
9. Ability to work effectively in afast-paced, dynamic environment with a high degree of flexibility andadaptability.
10. Regulatory affairs certifications(RAC) or other relevant professional certifications are a plus.
.svg)
