Director of Regulatory Affairs
Company: Disability Solutions
Location: Raleigh
Posted on: May 4, 2024
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Job Description:
** This role is in Raleigh, NC. We are considering candidates
open to relocation. It is onsite 3 days/remote 2 days/wk**Who We
Are: Harvesting Hope with a Growing FamilyAt Merz Therapeutics, we
take a nurturing approach to our organization - treating colleagues
like family, embracing our whole selves and creating a company
culture that encourages growth and decisive action. We are
committed to caring for whole communities by focusing on
individuals suffering from movement disorders and neurological
conditions and the healthcare providers dedicated to helping them,
while simultaneously bolstering our team members in a united effort
to make a difference.As a private, family-owned company, we have
the liberty and support to make decisions for ourselves, our
customers and the patients we serve. We pride ourselves on building
an inclusive culture where there is room to celebrate individual
growth and the ability to contribute to a common good as a
collaborative team. Our mission is grounded in a long-term view of
making a difference for the common good, while growing together as
a family.If you're looking to immerse yourself in a passionate team
rooted in community, connection and camaraderie, then we're looking
for YOU! #IAmMerzTxAre you ready to galvanize a team around a
culture of care, putting patients first to spark change?The
Director of Regulatory Affairs leads a small team of regulatory
professionals and is accountable for the regulatory affairs
deliverables under their supervision. This position will also
function as a Global Regulatory Lead on Global Project Team for
development of new indications for key portfolio products. The
position provides guidance on the development and execution of
regulatory strategies for new products and oversight of lifecycle
management of existing products. This position supports Marketing
and Legal teams on regulatory issues with potential business
impact, including participating in Promotional Review
Committee.Major dutiesDescriptionProject/Product regulatory
support--- Act as both an individual contributor when needed and a
coach for other team members on new product development
activities.--- Actively contribute to the development and execution
of global regulatory strategies for development and life-cycle
projects.--- Work with direct reports to identify, assess and
communicate regulatory risks and project issues as well as
recommend solutions to R&D senior management.--- Act as Global
Regulatory Lead (GRL) on at least one project team, working with
global regulatory affairs team to provide global strategy for new
indications for key portfolio product(s)Regulatory Submissions---
Interact with direct reports and project team members to ensure
high quality and timely regulatory submissions, which may include
submission planning and preparation.--- Ensure documents are in
compliance with current regulations and guidance and provide
strategic oversight.Sustaining Regulatory Support--- Ensure all
national registrations, licenses, listings and other certifications
are maintained as required for regulatory compliance.--- Support
commercialization and maintenance activities of products as needed,
including acting as primary regulatory reviewer on Promotional
Review Committee.Labeling--- Work with Commercial and R&D
colleagues to develop 'best in class' labeling.--- Review product
labeling for regulatory complianceLiaise with regulatory
agencies--- Primary point of contact for Global Health Authorities.
Communicate regulatory requirements and risks to internal
stakeholders.--- Interact with contract manufacturers, affiliates
and distributors. Regulatory Intelligence--- Conduct and analyze
regulatory research providing guidance to the business and project
teams on past precedence, competitive landscape and regulatory
intelligence. Management--- Mentor and provide guidance to staff.
Manage and supervise direct reports including work assignments and
performance feedback, appraisals and reviews.--- Manage regulatory
resources (budget and FTE) as needed.--- Communicate regulatory
requirements and risks to business leadership.Education-Bachelor's
Degree in scientific or health disciplineRequired-Master's degree
in scientific or health disciplinePreferred Professional
experience-Minimum 10 years relevant regulatory experience
Required-Direct experience with development, preparation and
submission of INDs, BLAs, and NDAs Required-Strong knowledge of US
drug and biologic regulatory environment and FDA regulations and
guidance Required-Previous experience managing
peoplePreferred-Experience with EU/International
RegulatoryPreferred-Experience with Combination Products,
particularly drug/devicePreferredDon't meet every single
requirement? Studies have shown that women and people of color are
less likely to apply to jobs unless they meet every single
qualification. At Merz Therapeutics we are dedicated to building a
diverse, inclusive, and authentic workplace, so if you're excited
about this role but your past experience doesn't align perfectly
with every qualification in the job description, we encourage you
to apply anyways. You may be just the right candidate for this or
other roles.Recruitment Note: Merz Therapeutics only sends emails
from verified "merz.com" addresses and never asks for sensitive,
personal information or money. If you have any doubts about the
authenticity of any type of communication from, or on behalf of
Merz Therapeutics, please contact Therapeutics.HR@merz.com
Keywords: Disability Solutions, Jacksonville , Director of Regulatory Affairs, Executive , Raleigh, North Carolina
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