Associate Director

At Lilly, we unite caring with discovery to make life better for people around the world.
We are a global healthcare leader headquartered in Indianapolis, Indiana.
Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We give our best effort to our work, and we put people first.
We're looking for people who are determined to make life better for people around the world.
At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world.
We are a global healthcare leader headquartered in Indianapolis, Indiana.
Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We give our best effort to our work, and we put people first.
We're looking for people who are determined to make life better for patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety ofBusiness Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.
Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI).
We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all.
Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Overview:
At Lilly, we serve an extraordinary purpose.
We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives.
Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared.
The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Regulatory and Scientific Expertise
Develop, Update and Execute US and Canada Registration Strategy
Initiate and Update Regulatory Strategy Document
Assist or lead in the development of
regulatory
strategy
by
leveraging
scientific, drug/device clinical development and
knowledge
from
FDA/HC
meetings
and
regulatory
trends.
Integrate
information
from the
external
environment,
product
specific
regulator
advice,
and
other
public
information
(i.e.,
Advisory
Committees)
to
develop
robust, innovative
regulatory
strategies.
Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by Lilly and knowledge of competitor labelling.
Monitor
upcoming
and
recent
approvals
of
competitive
development
programs/plans.
Integrate US/CA regulatory strategy into global registration strategy
Partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy
Communicate and share key information to enable seamless execution of US/Canada regulatory strategy
Provide input to clinical program to support market differentiation needs
Communicate the regulatory options and impact on proposed product development plans, seeking Senior Regulatory Scientist and management alignment.
Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets.
Collaborate with PRA and VEO for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planning
Support
development and update of labeling strategy to deliver market differentiation
Initiate
and update Claims Mapping, and Labeling Dashboard
Partner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g., Claims mapping) and network for alignment.
Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments.
Use global labelling strategy to influence the drug development strategy, as needed.
Create and communicate labeling dashboard to drive internal alignment on labeling strategy and key risks.
Develop and Update US and CA labeling, including prescribing information, patient labeling, device labeling (IFU) for new products and indications
Support the development of the US/Canadian labelling strategy in collaboration with Senior Regulatory Scientist and project personnel and network for alignment across affiliate labelling team to enable timely completion of US/Canadian product (drug and device) registration milestones (submission, approval, and launch).
Support strategic development of US/CA labelling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and provide responses to agency labelling questions.
Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling.
Support development of strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, PMA/510(k), and
de novo
Determine
and
communicate
submission
and
approval
requirements and regulator expectations.
Generate
regulatory
documents
for
submissions.
Ensure
the
regulatory
documents
contain
appropriate
data/information
based on regulator expectations
and are
clearly
written
to
articulate
Lilly's
scientific
position.
Anticipate
,
resolve, and communicate
key
technical,
operational,
and
strategic
issues
that
may
impact
other development
functions
or
the
development
team.
Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems.
Liaison with product and clinical development team and liaison with diagnostic developmentexperts
Provide
high
quality,
timely
and
decisive
regulatory
advice
that
enables
business
partners
to
make
well-informed
decisions
on
development of drugs
, diagnostics, devices, and
product
lifecycle
planning and business development
Communicate
regulatory
risks, potential impact and mitigation plans with
development
team leadership and
regulatory
management
Cultivate
relationships
with development teams.
Liaison with global marketing/NPP/VEO/Payer functions/US Brand Teams
Contribute to global and US launch-readiness plan and connect commercial partners (global marketing/NPP/VEO/Payer functions/US Brand Teams) with development teams to drive market differentiation strategy for assigned assets, including labelling and promotional deliverables throughout the product lifecycle
Cultivate
relationships
with
global marketing/NPP/VEO/Payer functions/US Brand Teams
.
Own relationship and interaction strategy with US and Canada regulatory authorities
Build,
maintain,
and
leverage
relationships
with
FDA,
Health Canada,
team members,
and
partner companies
as
appropriate.
Execute
high
quality
communications
with
FDA, Health Canada,
and
internal
customers
to
articulate
and ensure understanding of
the
regulatory
strategy
and
complex
issues.
Accountable
for
communications
to
the
regulator,
development
teams,
and
GRA, other development functions, Research, and BU leadership.
Advise/Approve US promotional strategy and claims
Review corporatecommunications press releases and social media posts
Set appropriate direction with Global Marketing and US Brand Team for development, review and approval of promotional claims
Partner with Regulatory Ad/Promo reviewer to advise US Brand Team on promotional strategy
Partner with Regulatory Ad/Promo reviewer to review
and
approve press materials and IR communications.
Lead/Influence/Partner
Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions
Model the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
Participate
in
forums
that
share
regulatory
information
across
GRA components and other Lilly teams and business partners
Constructively
challenge
teams
to
reach
the
best solutions
to
issues
Create
and
lead
in an
environment
that
encourages
open
discussions
on
issues
to
achieve
a
robust
outcome
on business
decisions
Minimum Qualification Requirements:
Bachelor's degree in scientific or health sciences discipline
Industry-related
experience
in
regulatory
affairs
and/or
drug
development
experience
for minimum of 5-8
years
Knowledge
of
FDA and Health Canada procedures
and
practices
across
Review
Divisions
and
awareness
of
evolving
regulatory
reform
initiatives desirable
Other Information/Additional Preferences:
Demonstrated
deep
knowledge
of the drug
development
process,
Lilly
regulatory/business
strategies
and
plans required
Demonstrated
ability
to
assess
and
manage
risk in a
highly
regulated
environment
Demonstrated
strong
written,
spoken
and
presentation
communication
Demonstrated
negotiation
and
influence
skills
Demonstrated
attention
to
detail
Demonstrated
effective
teamwork
skills; able
to
adapt
to
diverse
interpersonal
styles
Travel expected (10-15%)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (

) for further assistance.
Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lillydoes not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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