Associate Director, Regulatory Affairs - Labelling
Company: Ascendis Pharma A/S
Location: Palo Alto
Posted on: April 20, 2024
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Job Description:
The Regulatory Affairs (RA) Associate Director, Labelling will
be responsible for labelling activities across programs and stages
of development, with specific responsibility for the United States
and the Americas and supporting global needs as required. - -The RA
Associate Director, Labelling will be overall responsible for
ensuring compliance with US regulatory requirements for labeling,
and for coordinating internal labelling activities and processes
for regulatory submissions and product maintenance. The Associate
Director prioritizes their own work to meet agreed timelines and
works both independently and in a team environment. Global
coordination is also required and work with external partners may
be required. - -Key responsibilities: - - - - - - - - Drive process
for development and management of US & Americas labelling content
for initial and updated labels,---including working with the Global
Regulatory Lead for developing key messaging and strategy - - - - -
- - - Provide labeling advice and expertise on Company Core Data
Sheet (CCDS), USPI and Canadian Monograph content, and collaborate
with other market leads to develop local labeling in line with
global strategies and local regulations - - - - - - - - Coordinate
US labelling activities for regulatory submissions, product
maintenance and safety variations, including developing timelines,
involving relevant SMEs, and handling reviews - - - - - - - -
Understand and interpret regulatory requirements for labelling to
meet applicable regulations - - - - - - - - Perform global label
competitive intelligence, and make recommendations for actions - -
- - - - - - - Plan, support and advise in liaison and negotiation
with FDA and other agencies as needed for labelling content - - - -
- - - - Ensure and maintain tracking and archiving of approved
labels - - - - - - - - Develop project timelines and manage
labeling projects from initiation to completion - - - - - - - -
Contribute to development of key labelling processes and
infrastructure - - - - - - - - Work closely with global labelling
managers to ensure consistency and alignment - - - - - - - - BS/BA
or equivalent degree in a Scientific Discipline, advanced degree
desirable - - - - - - - - Regulatory experience of at least 8
years, and at least 3 years direct experience with labelling in the
US - - - - - - - - Solid knowledge of regulatory labelling
requirements in the US, have an understanding of current global and
regional trends and ability to assess the impact of these
requirements - - - - - - - - - Experience working in international
teams - - - - - - - - Excellent collaboration and communication
skills - - - - - - - - Preference for creative thinking and
solution development - - - - - - - - - Ability to interact
cross-functionally with members of commercial, legal, safety,
medical, and others - - - - - - - - Proficient in document editing
including Microsoft office applications (Word, PowerPoint, Excel) -
- - - - - - - Experience in systems (e.g. document management
systems, labeling systems, etc. - - - - - - - - Recognize when to
provide labeling guidance to product strategy teams, product review
teams, HA response teams, labeling stakeholders, junior team
members, or others as needed - - - - - - - - Strong understanding
of the purpose of the Target Product Label and CCDS and the
associated implications on labeling globally, downstream processes,
and compliance needs - - - - - - - - Participates with influence in
or leads departmental and cross-functional taskforces and
initiatives - - - - - - - - Interpret labeling regulations and
guidance - - - - - - - - Responds to challenging situations in a
calm and confident manner - - - - - - - - Embraces change and
quickly alters course in response to new challenges - - - - - - - -
Ability to travel up to 10% of the time domestically and
internationally -Estimated compensation: 180-200K/year
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Keywords: Ascendis Pharma A/S, Mountain View , Associate Director, Regulatory Affairs - Labelling, Executive , Palo Alto, California
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