Regulatory Affairs Director
Company: Disability Solutions
Location: Boston
Posted on: May 4, 2024
Job Description:
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 FMI's
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 FMI's
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 partner's 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:
- Bachelor's 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 FMI's values: innovation, patients,
collaboration, and passion
#LI-Hybrid
Keywords: Disability Solutions, Brookline , Regulatory Affairs Director, Executive , Boston, Massachusetts
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