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Senior Director Regulatory Affairs Strategy
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Senior Manager Regulatory Affairs, Strategy
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Inozyme Pharma Boston, United StatesSenior Manager/Associate Director, Regulatory Strategy · Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants. · Company Overview: · Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopha ...
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Senior Director Regulatory Affairs Strategy
1 week ago
EPM Scientific Boston, United StatesOur client, a clinical stage biotech company, is seeking an experienced and dynamic Director of Regulatory Affairs to join their team. This exciting opportunity offers the chance for someone with clinical regulatory lead experience and Oncology experience to take on a leadership ...
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Director, Medical Affairs Strategy, Gene Therapy
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AstraZeneca Boston, United StatesDirector, Global Regulatory Affairs, Development Strategy · This is what you will do: · Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with ...
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BioSpace Boston, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all inf ...
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Takeda Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
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BioSpace, Inc. Boston, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all in ...
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Takeda Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
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Workday Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that · the information I provide in my application will be processed in line with · Takeda's · Privacy Notice · and · Terms of Use . · I further attest that all ...
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Takeda Boston, United StatesAssociate Director, Congress Strategy Lead, Global Medical Affairs Oncology · At Takeda Oncology, we aspire to cure cancer, with inspiration from patients and innovation from everywhere. We value employees with diverse perspectives and backgrounds. As a member of our team, you w ...
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Director, Medical Affairs
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Verve Therapeutics Inc Boston, United StatesThe Position · The Director of medical affairs will be responsible for contributing to the overall medical affairs strategy and executing tactical plans. Priority activities include publications and medical communications, scientific congress execution, internal training material ...
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AstraZeneca PLC Boston, United StatesDo you have leadership skills and an in depth knowledge within Regulatory Affairs? Do you want to work on innovative projects of importance for our early Respiratory and Immunology portfolio? · At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and ...
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Senior Director, Medical Affairs
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Xenon Pharmaceuticals Inc. Boston, United StatesWho We Are: · Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are lookin ...
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Senior Director, Medical Affairs
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Xenon Boston, United StatesWho We Are: · Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are lookin ...
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Associate Director Medical Affairs
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Advanced Clinical Boston, United StatesAssociate Medical Director in Medical Affairs · Hybrid - on site part-time · Boston, MA · PERM - Fulltime · PharmD or PhD preferred · ** Motivated and ready to take on the Strategy of Medical Affairs team** · Responsibilities and Duties · • Work in close collaboration with Field ...
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Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead the new Disease Area of Hematology within the Global Medical Strategy group. This individual will be responsible for the development of Global Medical strategies for the first FDA ...
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Sr. Director of Regulatory Affairs
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Mantell Associates Boston, United StatesMantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for people with solid tumors/lung cancer and rare endocrine diseases, who are searching for a Director / Senior Director of Regulatory Affairs. · Director of Regulatory ...
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Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · The Executive Medical Director, Medical Affairs Hematology will provide medical leadership in the Medical Affairs function for our Hematology therapeutic area. This role will be accountable for leading and overseeing the US medical team for the development and i ...
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Edgewise Therapeutics Boston, United StatesAbout Edgewise Therapeutics · At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precisi ...
Senior Manager Regulatory Affairs, Strategy - Boston, United States - Inozyme Pharma
3 weeks ago
Description
Senior Manager/Associate Director, Regulatory Strategy
Company Overview:
Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. We are initially focused on developing a novel therapy, INZ-701, to treat the rare genetic diseases of ENPP1 and ABCC6Deficiencies. INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency.
Position Overview:
As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with regulatory requirements.
You will develop and implement US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. You will collaborate closely with cross-functional teams, including Clinical Development, Medical Affairs, Quality Assurance, and Commercial, to achieve regulatory milestones and support successful product development and commercialization.
Responsibilities:
Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
1. Develop and implement global regulatory strategies for rare disease therapeutic programs, ensuring alignment with corporate objectives and regulatory requirements.
2. Accountable for preparation and execution of regional aspects of the regulatory global strategy. Can include setting direction for junior staff to execute regional regulatory tasks according to strategy.
3. Provide strategic guidance and leadership to cross-functional teams on regulatory requirements, agency interactions, and submission strategies throughout the product lifecycle.
4. Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, BLAs, NDAs, and other relevant filings, ensuring compliance with applicable regulations and guidelines.
5. Monitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs
6. Proactively monitor and analyze regulatory trends, guidelines, and developments related to rare disease therapies, and provide strategic recommendations to senior management.
7. Serve as the primary point of contact for regulatory agencies (FDA, EMA, etc.), representing the company in interactions, meetings, and negotiations.
8. Collaborate with cross-functional teams to develop and execute regulatory communication plans, including scientific advice meetings, pre-submission meetings, and regulatory authority interactions.
9. Build and maintain effective relationships with key stakeholders, including regulatory agencies, key opinion leaders, and external consultants.
10. Stay current with evolving regulatory requirements and best practices, and ensure compliance with all applicable regulations, guidelines, and industry standards.
11. Provide regulatory guidance and support to internal teams to ensure compliance with regulatory obligations throughout the organization.
12. Mentor and develop regulatory team members, fostering a culture of excellence, collaboration, and continuous learning.
Qualifications:
1. Advanced degree (Ph.D., Pharm.D., or equivalent) in life sciences or a related field.
2. Minimum of 6 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on rare diseases and orphan drug development.
3. Strong knowledge of global regulatory requirements and guidelines for drug development and registration, including FDA and EMA regulations.
4. Proven track record of successfully leading regulatory strategy and submissions for rare disease therapeutic programs.
5. Experience with regulatory interactions, including FDA meetings (pre-IND, end-of-Phase 2, pre-NDA, etc.) and EMA scientific advice procedures.
6. Demonstrated ability to provide strategic regulatory guidance and effectively communicate complex regulatory information to cross-functional teams and senior management.
7. Strong leadership and people management skills, with the ability to motivate and develop high-performance teams.
8. Excellent written and verbal communication skills, with the ability to influence and negotiate with internal and external stakeholders.
9. Ability to work effectively in a fast-paced, dynamic environment with a high degree of flexibility and adaptability.
10. Regulatory affairs certifications (RAC) or other relevant professional certifications are a plus.
