|Global Digital Regulatory Lead|
Company: Otsuka Pharmaceuticals
Location: Princeton, NJ
Employment Type: Full Time
Date Posted: 09/15/2021
Expire Date: 11/15/2021
Job Categories: Biotechnology and Pharmaceutical
Global Digital Regulatory Lead|
Provides strategic regulatory expertise and leadership for global and regional health authority
interactions and submissions, and applies advanced theories and principles to develop new
practices and strategic approaches. With a focus o
n digital medical devices and therapeutics,
engages with digital alliances/forums to shape and develop regulatory and reimbursement
landscape and ensure Otsukas voice is heard with upcoming policy changes. Identifies
opportunities to enhance a develop all Otsuka digital assets including novel digital therapeutics
and SaMD products.
The Global Digital Regulatory Lead is in charge of leading efforts for advancing digital therapeutics
within Otsuka and being at the forefront within the regulatory landscape. This individual will be required
to meet with policymakers and engage in productive exchange progressing the advancement of these
novel products. Will represent Otsuka on all regulatory matters related to Software as a Medical Device
(SaMD), including meetings with executive leadership, meetings with FDA and other regulators and
entation within digital alliance associations, and working with our development
partners. As an expert in the field, applies strategy and principles to support the development of new
concepts and practices.
This role will contribute to the regulatory strategy for digital products and be at the forefront of the digital
landscape providing Otsuka with a cutting edge mindset that will progress digital therapeutics. This role
must be able to combine scientific, regulatory and business knowledge to assure that our products are
developed and distributed according to all applicable regulations for SaMD in alignment with the
companys strategic goals. This individual should have a very firm understanding of medical device
regulations and a creative approach to bringing safe and efficacious products to patients efficiently and
in a patient centric manner. This role will have high exposure across all functio
nal areas within Otsuka
and externally with multiple key audiences, such as scientific and clinical advisors, regulators, and
investors, and will advocate for the continuous advancement of the science and regulation of digital
� Meet with peer groups as well as policy makers to ensure new innovative products are made
available to patients in an efficient manner
Develop and implement a comprehensive set of policies and processes that support the rapidly changing SaMD space. � Establish policies/standards for novel digital therapeutic products. � Participates with other senior leaders to establish strategic plans and objectives.
� Effectively communicates and aligns with all executive stakeholders and ensures senior management has an up-to-date understanding of the current requirements and anticipates the future landscape and evolution of the digital therapeutics fiel
� Provide risk and compliance assessments concerning the company's products.
� Drive regulatory evaluation and guide on due diligence activities and provide regulatory assessment to management.
� Perform global regulatory intelligence including monitoring regulatory updates, workshops, discussions, and other news sources. Advance internal awareness of current and upcoming regulations, requirements and expectations, and identify training and educational needs for the organization.
� Serve as the internal go-to subject matter expert on regulatory matters concerning software as a medical device. This includes providing regulatory advice and oversight to other functional areas.
Bachelor's Degree required, preferred in life sciences, health care, or related discipline.
10+ years of experience in medical device regulatory affairs.
A comprehensive understand
ing and experience with implementation of medical device
regulations, including all relevant sections of Title 21 of the US Code of Federal Regulations and the
European Union Medical Device Directive (MDD) and/or Regulation (MDR).
Familiarity with the legal basis of FDAs regulatory authority, including the US Food, Drug &
Cosmetic Act and all related amendments.
Experience with regulatory matters concerning Software as a Medical Device (SaMD) and/or
Software in a Medical Device (SiMD).
Record of successful medical device filings, including 510(k), De Novo, PMA and/or CE Mark.
Familiarity with drug regulations and regulatory pathways, including drug-device combination
Experience with Quality Management Systems and applicable regulatory compliance
Expertise in GxP requirements for clinical, manufacturing
and other relevant practices.
Understanding of the principles and requirements of promotion, advertising and labeling.
Prior experience with international medical device regulatory requirements and marketing
Excellent writing and oral communication skills.
Ability to form and maintain working professional relationships with external stakeholders,
regulatory authorities and scientific and clinical advisors.
Prior experience and demonstrated ability to work in diverse therapeutic areas.
Strong leadership skills with ability to set a vision, lead change, grow a team and mentor others
Certification in regulatory affairs (such as RAC from the Regulatory Affairs Professionals
Prior leadership or management experience in the regulatory affairs departme
nt of a medical
device company that develops class II products
Experience with digital therapeutics
Experience with artificial intelligence and machine learning
Experience with combination drug-device products,
MS or PhD in a technical area