Senior Director, Regulatory Affairs - Devices and Diagnostics
Company: Ultragenyx Pharmaceutical
Location: Cambridge
Posted on: February 18, 2021
|
|
Job Description:
Senior Director, Regulatory Affairs - Devices and Diagnostics
Cambridge, MA / Ultragenyx - Gene Therapy - Regulatory Affairs /
Ultragenyx is a commercial-stage biopharmaceutical company
committed to developing and commercializing novel therapies for the
treatment of rare and ultra-rare genetic diseases. The company has
rapidly built a diverse portfolio of small molecules, biologics,
gene therapies and nucleic acids to target debilitating genetic
diseases for which the unmet medical need is high, the biology for
treatment is clear, and for which there are typically no approved
therapies treating the underlying disease. Ultragenyx Gene Therapy
is headquartered in Cambridge, MA with additional locations in
Woburn, MA. We are looking for exceptional individuals who share
our passion for developing novel therapies to treat rare diseases
and advancing the field of gene therapy. Developing new treatments
for rare genetic diseases is challenging work. It takes courage,
talent, and dedication to look past the easy answers and uncover
new solutions that can make a meaningful impact. At Ultragenyx we
push each other to perform at our very best, because we never lose
sight of our mission - to make a difference in our patients' lives.
Come join our team during this exciting time of growth and
opportunities!-- During the COVID-19 Outbreak we are committed to
our hiring process. The health and safety of our employees and
prospective employees take priority which means at this time our
process will include remote based web-ex video discussions,
interviews & onboarding. Position Summary Ultragenyx is seeking an
experienced and highly motivated Sr. Director, Regulatory Affairs -
Devices (Gene Therapy), who is a team builder and enjoys a fast
paced, dynamic work environment. The Sr. Director will be
responsible for developing and implementing global (US, EU, and
other regions) regulatory strategies and processes for in-vitro
diagnostics (IVDs)/ companion diagnostics (CDx's), while also
maintaining oversight of these global regulatory strategies for all
projects with an IVD/CDX component. The Sr. Director will establish
sustainable processes, assure informed relationships, and deliver
strategic outcomes. The responsibilities include providing critical
strategic and tactical IVD/CDx global regulatory guidance that
positively influences project planning and decision making. The
individual will be responsible for developing and maintaining the
IVD/CDx strategy template while advising on strategies that are
aligned with Ultragenyx gene therapy objectives. The individual
will participate in project review meetings and propose ideas to
facilitate improved collaboration. The individual will also
maintain awareness of the global regulatory environment and assess
and communicate impact of changes in the area of personalized
medicine, with special focus on diagnostic tests. This position
will report to the Vice President of Regulatory Affairs, Gene
Therapy. Responsibilities
Keywords: Ultragenyx Pharmaceutical, Cambridge , Senior Director, Regulatory Affairs - Devices and Diagnostics, Executive , Cambridge, Massachusetts
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Executive JobsEVP Chief Operating Officer Description: Reporting to the President/CEO, the Executive Vice President/Chief Operating Officer COO has overall operational responsibility for the acute care services of Company including: South Shore Hospital, (more...) Company: ExecuNet Location: Weymouth Posted on: 02/28/2021 Engineering Program Manager Description: Sorry, the job you are trying to apply for has been filled. br Searchhere --to view current openings. PLAN FOR SUCCESS CAREER OPPORTUNITIES Our business encompasses many different functions and capabilities, (more...) Company: Abbott Laboratories Location: Plymouth Posted on: 02/28/2021 Director, Advanced Analytics Description: Cutting-edge doesn't even begin to describe it Use your machine learning skills to transform healthcare Location: Plymouth Meeting, Pennsylvania Company: IQVIA Argentina Location: Plymouth Posted on: 02/28/2021 Domino's General Manager in Training - Melrose - Earn btw $15 - $18 per hour FIRST YEAR (3716) Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...) Company: Domino's Location: Brookline Posted on: 02/28/2021 Director of Property Management Description: 90 Longwood Avenue br Brookline , MA br United States Job Description Position Title: Director of Property Management The Director of Property Management is a results-driven leader responsible for (more...) Company: CITIZENS HOUSING & PLANNING Location: Brookline Posted on: 02/28/2021 Domino's General Manager in Training - Salem - Earn btw $15 - $18 per hour FIRST YEAR (3770) Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...) Company: Domino's Location: Salem Posted on: 02/28/2021 Assistant Property Manager Description: Are you looking to develop your skills in Property Management We are looking for candidates that are eager to apply their superior leasing and marketing experience into the next step of their career as (more...) Company: Fairfield Residential Location: Chelsea Posted on: 02/28/2021 Director of Strategy, 40Hrs, Cardiovascular Medicine-One Brave Idea Description: Job Description - Director of Strategy, 40Hrs, Cardiovascular Medicine-One Brave Idea 3136538 Director of Strategy, 40Hrs, Cardiovascular Medicine-One Brave Idea - 3136538 One Brave Idea OBI (more...) Company: CTI Education Group Location: Brookline Posted on: 02/28/2021 Domino's General Manager in Training - Melrose - Earn btw $15 - $18 per hour FIRST YEAR (3716) Description: ABOUT THE JOB You were born to be the boss. We know. You get up in the morning and you make sure everyone else in the house is doing what they need to do. Then you go to work and you make sure that everyone (more...) Company: Domino's Location: Salem Posted on: 02/28/2021 Vice President Finance Description: Job Description:The Arctaris family of funds Arctaris is seeking a full-time Vice President of Finance in its Chestnut Hill, MA home office. The VP of Finance will help manage the financial oversight (more...) Company: Arctaris Impact Investors Location: Brookline Posted on: 02/28/2021 |