Regulatory Affairs Director
2 weeks ago
About the Job
The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMIs unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including registration of new products and regulatory activities for on-market products across the globe. This role will also be responsible for other key projects within Regulatory Affairs, as applicable. This role requires creative and strategic thinking and excellent communication skills and partners closely with cross-functional stakeholders in Commercial, BioPharma, Operations, R&D, and Technology. As a member of the RA leadership team, this role contributes to the overall development and delivery of the department strategy and vision, provides insights for decision-making, and leads or sponsors department-wide and cross-functional projects.
Key Responsibilities
- Develop and drive international regulatory strategy covering FMIs assay products, specimen collection kits, software, and laboratory operations:
- Lead cross-functional initiatives to improve regulatory strategy of international product registrations.
- Develop and implement international regulatory strategy to address IVD regulations in EU and Ex-US countries for IVD, CTA, and CDx submissions.
- Identify innovative and novel regulatory approaches to software, data and digital products; new assay and biomarker product launches and major platform updates; mature assay products and minor on-market product changes; CTA, and companion diagnostic submissions and approvals across all products.
- Provide regulatory guidance and strategy pertaining to product development.
- Influence regulatory strategy both within the organization as well as externally with pharmaceutical partners.
- Lead other key projects, as applicable.
- Drive Cross-Functional Collaboration and Strategies:
- Establish strong partnerships and relationships with internal stakeholders across the Roche enterprise.
- Ensure proactive and effective communication across the organization.
- Strategically represent Regulatory Affairs on cross-FMI and cross-Roche initiatives.
- Partner with cross-functional colleagues to continuously drive improvement and innovation across products and processes.
- Recognize and act upon value-generating opportunities in the context of new and existing collaborations by bringing together a team of internal stakeholders.
- Contribute as a thought-partner for innovative global strategy.
- External Relationship Management:
- Establish strong partnerships and relationships with external stakeholders.
- Ensure proactive and effective communication with external partners.
- Leverage understanding of partners structure, people, strategy, and communication style and processes to inform decisions.
- Creatively approach challenges and problem resolution to optimize submission strategies with international regulatory bodies Influence regulatory policy with regulatory bodies and industry consortia.
- Maintain Knowledge of Evolving Regulatory Landscape:
- Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on Regulatory Affairs projects and make modifications as necessary.
- Maintain knowledge of current IVD and device regulations and guidelines and company policies, SOPs and procedures.
- Other duties pertinent to Regulatory Affairs as occasionally assigned.
Qualifications:
Basic Qualifications:
- Bachelors Degree and 12+ years of demonstrated experience in device or digital product, pharmaceutical/biologics regulatory, or scientific discipline including at least 5 years of demonstrated experience specifically in regulatory affairs; OR
- Advanced Degree in science, law, health policy, regulatory affairs or engineering and 8+ years of demonstrated experience in device, pharmaceutical/biologics regulatory, or scientific discipline including at least 3 years of demonstrated experience specifically in regulatory affairs work
Preferred Qualifications:
- Masters or Advanced Degree in a science, law, health policy, regulatory affairs or engineering discipline
- 12+ years of professional work experience in a molecular testing laboratory, diagnostic manufacturing organization and/or a diagnostics service organization
- 6+ years working in a regulatory affairs department executing or overseeing regulatory submissions
- Experience engaging in direct negotiations with the FDA, PDMA, EMA, Notified Bodies, or other regulatory bodies
- Experience preparing and submitting successful global marketing authorization applications
- An understanding of the multiple routes to clearance or approval of a diagnostic product
- Ability to influence and negotiate effective solutions through leading change and driving for results
- Strong analytical skills and ability to apply strategic-thinking and problem-solving skills to meet business objectives
- Outstanding presentation and communication skills
- Strong history of achievement demonstrated by leadership activities, publications, presentations or other activities
- Collaboration skills and the ability to effectively communicate (written and oral) with internal and external team members on project activities
- Highly effective teamwork and collaboration skills
- History of leadership and track record of applying strategic and system thinking
- Proven history of successful global regulatory registrations and approvals for IVD products
- Understanding of HIPAA, GDPR and importance of patient safety and data privacy regulations and guidelines
- Commitment to FMIs values: innovation, patients, collaboration, and passion
#LI-Hybrid
-
Director/Assoc Director Regulatory Affairs
4 weeks ago
Boston, United States Apex Systems Full timeJob#: 2025096 Job Description: Associate Director/Director, Regulatory Affairs 2025096 Location: Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation,...
-
Regulatory Affairs Director
2 weeks ago
Boston, United States Foundation Medicine Full timeAbout the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI’s unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy,...
-
Regulatory Affairs Director
2 weeks ago
Boston, Massachusetts, United States Foundation Medicine Full timeAbout the JobThe Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...
-
Senior Director, Regulatory Affairs
2 weeks ago
Boston, Massachusetts, United States Proclinical Full timeSenior Director, Regulatory Affairs - Permanent - RemoteProclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. This is a permanent role with the opportunity to work remotely.Primary ResponsibilitiesIn this role, you will provide leadership and advice on the...
-
Senior Director, Federal Affairs
7 days ago
Boston, United States BlueCross & BlueShield of Massachusetts Full timeThe Senior Director, Federal Government Affairs will manage BCBSMA activities to achieve effective and time-sensitive advancement of BCBSMA legislative and regulatory agenda in a coordinated and integrated fashion. Key Accountabilities: Manage BCBSMA Director, Senior, Regulatory Affairs, Vice President, Government, Insurance, Policy
-
Senior Director, Regulatory Affairs
4 weeks ago
Boston, United States HilleVax, Inc. Full timeHilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...
-
Director, Regulatory Affairs Vaccines Cmc
4 weeks ago
Boston, United States ARIAD Full time**Pay Range**: $169,400.00 - $266,200.00 **Job ID** R0120763**Date posted** 04/16/2024**Location** Boston, Massachusetts**Pay Range** $169,400.00 - $266,200.00**About the role**: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four...
-
Director, Regulatory Affairs Vaccines Cmc
4 weeks ago
Boston, United States Takeda Pharmaceutical Full time**About the role**: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join...
-
Senior Manager Regulatory Affairs, Strategy
3 weeks ago
Boston, United States Inozyme Pharma Full timeSenior 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...
-
Director, Regulatory Affairs
5 days ago
Boston, United States Imbria Pharmaceuticals Full timeCompany Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
-
Senior Manager Regulatory Affairs, Strategy
3 weeks ago
Boston, United States Inozyme Pharma Full timeSenior Manager/Associate Director, Regulatory StrategyCompany 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...
-
Senior Manager Regulatory Affairs, Strategy
3 weeks ago
Boston, United States Inozyme Pharma Full timeSenior Manager/Associate Director, Regulatory StrategyCompany 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...
-
Principal Regulatory Affairs Specialist
4 days ago
Boston, United States BRIOHEALTH SOLUTIONS INC Full timeJob DescriptionJob DescriptionPrincipal Regulatory Affairs SpecialistJob DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc., you’ll support product development activities for Class III...
-
Director, Regulatory Affairs
2 weeks ago
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
-
Senior Director, Regulatory Strategy
4 weeks ago
South Boston, United States Inozyme Pharma Full timeSenior 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.Position Overview: As the Senior Director of Regulatory Strategy, you...
-
Regulatory Affairs Specialist
5 days ago
Boston, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Interpret regulatory filings and lead cross-functional teams to comply with new or revised regulations. Cultivate relationships within Customer Operations, throughout the Company and with external stakeholders. Partner with Corporate Affairs, Rate Engineering, Law, Customer Energy Solutions, Corporate Accounting and IT, and other...
-
Head of Regulatory Affairs
2 weeks ago
Boston, United States Discera Search Full timeLead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next. Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early...
-
Regulatory Affairs Associate
2 weeks ago
Boston, United States INTELLECTT INC Full timeRole: Regulatory Affairs Associate Location: Remote Duration: 7 Months Main Responsibilities Provide regulatory input to product lifecycle planning. Assist in SOP development and review. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand and investigate regulatory history/background of...
-
Regulatory Affairs Associate
2 weeks ago
Boston, United States WHITE COLLAR TECHNOLOGIES INC Full timeJob DescriptionJob DescriptionJob DescriptionWe have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. All of these roles will interface with clients on different projects to provide consulting services.We are seeking entry-level experienced personnel or fresh graduate students willing...
-
Director of Government Affairs
1 week ago
Boston, United States State of Massachusetts Full timeThe Massachusetts Sheriffs Association (MSA) is actively seeking a visionary leader to fill the role of Director of Government Affairs. If you are passionate about reshaping the future of corrections, advancing modern training initiatives for correct Director, Government, Deputy Sheriff, Management