Senior Director Regulatory Affairs
Company: Bridgeway Professionals
Location: Jersey City
Posted on: June 20, 2022
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Job Description:
COMPANY is a publicly traded biotechnology company pioneering
innovative medicines to help millions of patients worldwide
overcome and prevent difficult-to-treat infections that are
becoming increasingly drug-resistant. They marketed product and
strong pipeline.They are seeking an experienced Senior Director,
Regulatory Affairs. Company located in Jersey City, NJ and will
consider this person to work from home as long as they could be in
office at least one or two days a week (preferable Tuesday or
Wednesday or Thursday OR every other week for a few days). MAY
consider coming in just once a month for entire week. We are
committed to positively impacting the lives of patients by
developing innovative therapies, come join us and make a
difference.Position Summary:The Senior Director, Regulatory Affairs
is responsible for providing subject matter expertise on matters
related to global regulatory activities, as well as providing
leadership for the growth and responsibilities of the regulatory
department. The Senior Director will represent COMPANY in key
stakeholder and strategy meetings on regulatory matters related to
medical product development and commercialization, including
meetings with executive leadership, meetings with the Food and Drug
Administration (FDA) and other regulators. This role leads
preparation, review and submission of documents to the FDA and
other regulatory authorities to support product development leading
to marketing authorization and lifecycle management. This role
combines scientific, regulatory and business knowledge to assure
that COMPANY products are developed and distributed according to
all applicable regulations in alignment with the company's
strategic goals. The role requires a mastery of medical product
regulations to develop efficient solutions to the evolving
regulatory needs of the industry.Responsibilities:Secure US and
global regulatory marketing authorization for new products, product
updates and product expansions. This includes preparation and
filing of submissions, responding to regulatory authorities and
auditors, and leading meetings with regulatory authorities.Develop
and implement a comprehensive set of policies, processes and SOPs
in support of the organizations regulatory responsibility.Formulate
regulatory strategies for pipeline products.Anticipate regulatory
obstacles and emerging issues throughout the product lifecycle and
develop strategies for resolution.Perform global regulatory
intelligence including monitoring regulatory updates, workshops,
discussions, and other news sources.Advance internal awareness of
current and upcoming regulations, requirements, and expectations,
and identify training and educational needs for the
organization.Manage processes involved with maintaining annual
licenses, registrations, and listings.Serve as an internal go-to
subject matter expert on regulatory and quality matters.Represent
the company in external meetings on regulatory matters, including
with regulators and auditors and development partners.Requirements
and Preferred Skills:Advanced Life Science Degree required (PharmD,
PhD, MD, MA)15+ years of experience in regulatory affairs.
Progressive responsibility and leadershipA comprehensive
understanding and experience with implementation of medical product
regulations, particularly all relevant sections of Title 21 of the
US Code of Federal RegulationsKnowledge of global regulatory
agencies/processes/regulationsRecord of successful medical product
filings such as INDs, NDAs, BLAs, MAAsExcellent writing and oral
communication skillsAbility to form and maintain working
professional relationships with external stakeholders, regulatory
authorities and scientific and clinical advisorsPrior experience
and demonstrated ability to work in diverse therapeutic areasStrong
leadership skills with ability to set a vision, lead change, grow a
team and mentor othersExperience leading regulatory authority
communications and meetingsEmployment is contingent upon
satisfactory results of a pre-employment background check, drug
screen, proof of full COVID-19 vaccination and proof of COVID-19
booster vaccination BE THE CHANGE YOU WISH TO SEE IN THE WORLD -
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Keywords: Bridgeway Professionals, Jersey City , Senior Director Regulatory Affairs, Executive , Jersey City, New Jersey
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