AD/Director Reg Affairs (Anti-Viral)
Company: Joul--
Location: Florham Park
Posted on: March 12, 2025
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Job Description:
Job Title: AD/Director Regulatory Affairs (Anti Viral
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Location: Florham Park, NJ 07932 - 50% hybrid
Must live a commutable distance to our US Corporate Headquarters
in, NJ. Office presence required at least 50% of the time per
month
Type: Direct Hire
Overview
The Associate Director/Director, Regulatory Affairs - Global
Development Products (Anti-Viral), provides essential support to
the Executive Director in overseeing regulatory activities related
to antiviral initiatives on a regional and/or global scale. This
role involves assisting in the development and execution of
regulatory strategies, regulatory submissions, and fostering
collaboration with regional regulatory authorities. The Associate
Director will work closely with cross-functional teams to integrate
antiviral considerations into product development, manufacturing,
and commercialization processes. This position plays a pivotal role
in ensuring alignment with company goals, regional requirements,
and best practices to achieve successful outcomes for our antiviral
initiatives.
Responsibilities
Support the Executive Director in developing and executing regional
regulatory strategies for antiviral initiatives within specific
regions.
Assist in providing strategic oversight and leadership to the
regulatory team, ensuring alignment with company objectives and
regional regulatory requirements.
Contribute to the preparation and submission of regulatory
documents related to antiviral initiatives to regulatory
authorities.
Collaborate with cross-functional teams to integrate antiviral
considerations into product development, manufacturing, and
commercialization processes.
Assist in fostering relationships with regional regulatory
authorities to facilitate communication, negotiations, and
interactions related to antiviral initiatives.
Support in monitoring regulatory developments, changes, and trends
within specific regions, and provide insights to the Senior
Director.
Assist in managing regulatory risks and opportunities related to
antiviral initiatives and contribute to developing mitigation
strategies as needed.
Provide regulatory guidance and support for post-marketing
activities related to antiviral initiatives, including variations,
renewals, labeling updates, and compliance initiatives.
Collaborate with the regulatory team to represent the company's
interests in industry forums, working groups, and regulatory
meetings related to antiviral initiatives.
Support the Senior Director in serving as a subject matter expert
on regional regulatory requirements, guidelines, and best practices
related to antiviral initiatives.
Assist in coordinating with global regulatory counterparts to
ensure alignment of regional regulatory strategies and submissions
with global development plans and corporate objectives.
Assist in preparing regulatory updates, progress reports, and
strategic recommendations to senior and/or executive leadership and
regulatory governance committees.
Other duties as assigned.
Qualifications Bachelor's degree in a scientific discipline such as
life sciences, pharmacy, bioscience; advanced degree preferred.
7+ years (Associate Director)/ 10+ years (Director) of experience
in regulatory affairs within the pharmaceutical or biotech
industry, with a focus on antiviral products preferred.
Demonstrated ability to work effectively in a cross-functional team
environment.
Strong knowledge of regional regulatory requirements and
guidelines, including FDA regulations and ICH guidelines.
Excellent communication and interpersonal skills.
Benefits
Our client provides a comprehensive benefits package.
Keywords: Joul--, New York , AD/Director Reg Affairs (Anti-Viral), Executive , Florham Park, New York
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