Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
Company: Disability Solutions
Location: Madison
Posted on: October 19, 2024
Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.Bristol Myers Squibb recognizes the
importance of balance and flexibility in our work environment. We
offer a wide variety of competitive benefits, services and programs
that provide our employees with the resources to pursue their
goals, both at work and in their personal lives. Read more: .
Position Responsibilities
- Leadership responsibility for global regulatory strategy to
support the development of biomarkers, companion diagnostic tests,
digital health and other devices to enhance the value of our
pharmaceutical products across therapeutic areas
- Responsible for understanding the regulatory landscape,
assessing regulatory risk, and developing global filing
strategies.
- Co-lead marketing application submission teams for indications
that are at regulatory filing stage to develop content strategy for
global dossiers.
- Ensure consistent positions are presented in responses to
global Health Authority (HA) queries.
- Ensure global development plans will meet global regulatory
requirements by soliciting and integrating regional regulatory
strategy liaison input. In collaboration with the Global Regulatory
sub-team, develop global submission plans and HA interaction
plans.
- Provide input into the development of protocol synopses and
protocols. Contribute in cross-functional rapid response teams to
respond to Clinical Trial Application (CTA) queries on new
protocols and protocol amendments in compliance with HA
deadlines.
- Contribute in the developing of target labeling. Degree /
Experience Requirements
- Bachelor's degree required; advanced scientific degree
preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the
industry with at least 4+ years of US Medical Device Regulatory
Affairs experience Key Competencies
- Experience in successfully leading teams; ability to broadly
represent the regulatory functions on project teams within BMS and
across alliance. Experience utilizing leadership techniques to
drive a team through the stages of team development.
- Experience with developing regulatory strategies in
coordination with clinical plans and marketing objectives.
- Experience with clinical trial assays (CTA) in drug clinical
trials in communicating between Diagnostic sponsor and Drug
sponsor.
- Experience as a member of Global Regulatory sub-team, project
working groups, or comparable experience in the industry.
Experience coordinating communications within teams and across
functions.
- Experience with communication of regulatory strategy, issues,
and risks in written and verbal format to governing bodies.
- Ability to apply project management techniques within teams and
effectively manage meetings.
- Demonstrated ability to breakdown complex, scientific content
into logical components.
- Ability to coordinate global activities, facilitate issue
resolution and conflict management.
- Demonstrated ability to drive quality decision-making and
ability to organize/prioritize tasks.
- Demonstrated ability to negotiate with and influence
others.
- Understanding of strategic and tactical role for the drug
development process.
- Understanding of general global regulatory requirements for
drugs in development.
- Understanding of R&D process and specific regulatory
responsibilities/deliverables for the company decision points. For
roles based in Washington, DC - The starting compensation for this
job is a range from $156,000 - $195,000, plus incentive cash and
stock opportunities (based on eligibility). The starting pay rate
takes into account characteristics of the job, such as required
skills and where the job is performed. Final, individual
compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may
vary based on the job and location. For more on benefits, please
visit . Benefit offerings are subject to the terms and conditions
of the applicable plans then in effect and may include the
following: Medical, pharmacy, dental and vision care. Wellbeing
support such as the BMS Living Life Better program and employee
assistance programs (EAP). Financial well-being resources and a
401(K). Financial protection benefits such as short- and long-term
disability, life insurance, supplemental health insurance, business
travel protection and survivor support. Work-life programs include
paid national holidays and optional holidays, Global Shutdown Days
between Christmas and New Year's holiday, up to 120 hours of paid
vacation, up to two (2) paid days to volunteer, sick time off, and
summer hours flexibility. Parental, caregiver, bereavement, and
military leave. Family care services such as adoption and surrogacy
reimbursement, fertility/infertility benefits, support for
traveling mothers, and child, elder and pet care resources. Other
perks like tuition reimbursement and a recognition program.
#li-hybrid If you come across a role that intrigues you but doesn't
perfectly line up with your resume, we encourage you to apply
anyway. You could be one step away from work that will transform
your life and career. Uniquely Interesting Work, Life-changing
CareersWith a single vision as inspiring as Transforming patients'
lives through science--- , every BMS employee plays an integral
role in work that goes far beyond ordinary. Each of us is empowered
to apply our individual talents and unique perspectives in an
inclusive culture, promoting diversity in clinical trials, while
our shared values of passion, innovation, urgency, accountability,
inclusion and integrity bring out the highest potential of each of
our colleagues.On-site Protocol BMS has a diverse occupancy
structure that determines where an employee is required to conduct
their work. This structure includes site-essential, site-by-design,
field-based and remote-by-design jobs. The occupancy type that you
are assigned is determined by the nature and responsibilities of
your role: Site-essential roles require 100% of shifts onsite at
your assigned facility. Site-by-design roles may be eligible for a
hybrid work model with at least 50% onsite at your assigned
facility. For these roles, onsite presence is considered an
essential job function and is critical to collaboration,
innovation, productivity, and a positive Company culture. For
field-based and remote-by-design roles the ability to physically
travel to visit customers, patients or business partners and to
attend meetings on behalf of BMS as directed is an essential job
function. BMS is dedicated to ensuring that people with
disabilities can excel through a transparent recruitment process,
reasonable workplace accommodations/adjustments and ongoing support
in their roles. Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to . Visit to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your area.If
you live in or expect to work from Los Angeles County if hired for
this position, please visit this page for important additional
information: Any data processed in connection with role
applications will be treated in accordance with applicable data
privacy policies and regulations.
Keywords: Disability Solutions, Union , Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics), Executive , Madison, New Jersey
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