AstraZeneca GmbH
The
Associate
Regulatory Affairs Director (RAD)
, Regulatory Science & Execution
will be
accountable
for
the
develop
ment,
implement
ation and maintenance of
regulatory strategies for assigned
project(s)/
product
(s)
and regulatory jurisdiction
(
s
)
, with the intention of achieving
successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will
provide
tactical
and strategic input to
and leadership
across
regulatory and
cross-functional teams
with the
objective
of delivering according to regional
and
global Business Objectives.
The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities. You will
be responsible for
: Accountable for the
regulatory execution
of submissions
in the relevant regulatory
jurisdiction
(s)
,
by
actively collaborating with other Regulatory functions
and cross-functional teams
(
e.g.
clinical trial applications, marketing authorization applications,
orphan drug designation applications,
paediatric
submissions,
etc.)
. A ctively be up to date on
latest
regulatory requirements and
trends, and
contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca’s internal knowledge and
expertise
. Supports relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support. Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and
participate
in mentoring, and performance feedback to regulatory and cross-functional colleagues. Ensure
exemplary behavior,
leadership,
ethics
and transparency
within the
Enteprise
, with Health Authorities and other external stakeholders. Qualifications: Bachelor’s Degree
, life science
Postgraduate degrees relevant to the role (
e.g.
MSc, PhD
, PharmD, MD
)
a plus
7+
years of
relevant
Regulatory experience
in the pharmaceutical industry
, with
experience in regional regulatory
s
trategies
(
e.g.
EU, US,
UK, Canada
)
.
Strong knowledge of drug development and regulatory
environment
,
coupled
by excellent scientific and business judgment.
Experience
providing
strategic regulatory advice
in
at least one
several
regulatory
jurisdiction
(s)
(
e.g.
EU, US,
Canada, UK
)
for the global development of products through
most
stages of development including pre-approval and marketed
assets
.
A
bility to manage complex issues and
lead
multiple projects simultaneously
in a time-sensitive fashion.
Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization
, especially Senior Management.
Strong interpersonal, written/verbal communication
and presentation
skills.
Proven
track record
practicing sound judgment as it relates to risk assessment
Highly
conversant
and knowledgeable of new and emerging regulations and
guidances
. Understanding of
GxPs
at
relevant areas and
solid understanding of where to
seek
and how to interpret regulatory information.
Excellent use of Microsoft 365 (Office) tools, ideally
well skilled on the use of PowerPoint
Experience working in regulatory documentation system (like Veeva)
Proficient in English in the Corporate setting. Additional languages are a plus
A
dditional certification and/or training relevant to the role
When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines. Our commitment to transparency, objectivity, and ethics drives us to meet unmet medical needs. With our global reach and resources, we are shaping the future of rare disease treatment, helping people live their best lives. Ready to make a difference? Apply now! Date Posted 06-Aug-2025
Closing Date 20-Aug-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr
Associate
Regulatory Affairs Director (RAD)
, Regulatory Science & Execution
will be
accountable
for
the
develop
ment,
implement
ation and maintenance of
regulatory strategies for assigned
project(s)/
product
(s)
and regulatory jurisdiction
(
s
)
, with the intention of achieving
successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will
provide
tactical
and strategic input to
and leadership
across
regulatory and
cross-functional teams
with the
objective
of delivering according to regional
and
global Business Objectives.
The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities. You will
be responsible for
: Accountable for the
regulatory execution
of submissions
in the relevant regulatory
jurisdiction
(s)
,
by
actively collaborating with other Regulatory functions
and cross-functional teams
(
e.g.
clinical trial applications, marketing authorization applications,
orphan drug designation applications,
paediatric
submissions,
etc.)
. A ctively be up to date on
latest
regulatory requirements and
trends, and
contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca’s internal knowledge and
expertise
. Supports relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support. Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and
participate
in mentoring, and performance feedback to regulatory and cross-functional colleagues. Ensure
exemplary behavior,
leadership,
ethics
and transparency
within the
Enteprise
, with Health Authorities and other external stakeholders. Qualifications: Bachelor’s Degree
, life science
Postgraduate degrees relevant to the role (
e.g.
MSc, PhD
, PharmD, MD
)
a plus
7+
years of
relevant
Regulatory experience
in the pharmaceutical industry
, with
experience in regional regulatory
s
trategies
(
e.g.
EU, US,
UK, Canada
)
.
Strong knowledge of drug development and regulatory
environment
,
coupled
by excellent scientific and business judgment.
Experience
providing
strategic regulatory advice
in
at least one
several
regulatory
jurisdiction
(s)
(
e.g.
EU, US,
Canada, UK
)
for the global development of products through
most
stages of development including pre-approval and marketed
assets
.
A
bility to manage complex issues and
lead
multiple projects simultaneously
in a time-sensitive fashion.
Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization
, especially Senior Management.
Strong interpersonal, written/verbal communication
and presentation
skills.
Proven
track record
practicing sound judgment as it relates to risk assessment
Highly
conversant
and knowledgeable of new and emerging regulations and
guidances
. Understanding of
GxPs
at
relevant areas and
solid understanding of where to
seek
and how to interpret regulatory information.
Excellent use of Microsoft 365 (Office) tools, ideally
well skilled on the use of PowerPoint
Experience working in regulatory documentation system (like Veeva)
Proficient in English in the Corporate setting. Additional languages are a plus
A
dditional certification and/or training relevant to the role
When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines. Our commitment to transparency, objectivity, and ethics drives us to meet unmet medical needs. With our global reach and resources, we are shaping the future of rare disease treatment, helping people live their best lives. Ready to make a difference? Apply now! Date Posted 06-Aug-2025
Closing Date 20-Aug-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr