Sr Manager, Regulatory Affairs - Strategy
Company: Horizon Therapeutics
Location: Bethesda
Posted on: November 20, 2022
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Job Description:
Working at Horizon is more than a job - it's personal. For us,
success is measured by the numbers that matter most - the number of
lives we touch, the number we change and those we work tirelessly
to help save. We're a team of agile, out-of-the-box thinkers who
are inspired to do more because we know we're a part of something
bigger. We strive to build meaningful careers at a company whose
values we share because when we live up to our potential, we help
others live up to theirs.
Position Summary:
This position is responsible for the regulatory support of products
marketed in the U.S., E.U., and rest-of-the-world (ROW) as well as
development stage products. This position is also responsible for
coordinating all aspects of regulatory submissions for assigned
projects, providing guidance on post-approval changes, assisting in
developing regulatory strategy, and representing the function on
cross-functional teams.
Responsibilities:
Assist in the development and implementation of regulatory
strategies for investigational
and commercial drug products
Provide required regulatory documentation for health authority
submissions and
subsequent amendments/variations/supplements
Provide oversight of clinical research organizations managing rest
of world regulatory
submissions and correspondences
Assist in providing guidance on the content and suitability of
regulatory documents for
submission
Assist in providing interpretative analyses of complex regulatory
guidance documents,
regulations, or directives that impact the company's products and
operations
Manage project deliverables and timelines and ensures all
assignments meet regulatory and
other company guidelines
Assist in providing input into the response strategy for health
authority queries
Draft responses to health authority queries, track responses and
regulatory commitments
Participate in regulatory agency inspections, as required
Keep abreast of industry trends with respect to regulatory policies
and procedures within
the EU, US, and ROW
Ensures quality and compliance of regulatory activities by adhering
to established corporate
and functional processes, guidelines and SOP's
Cultivates relationships with key colleagues in other parts of the
organization
Mentors, develops, and assesses direct reports including monitoring
and managing
workload and assignments if applicable
Qualifications and Skills Required
Minimum BA/BS in related scientific discipline (biology, chemistry,
biochemistry, immunology,
pharmacy)
5-9 years regulatory affairs experiences preferably involving
direct contact with regulatory
agencies, full knowledge of FDA, EU and ICH regulations and
guidelines and the ability to assist
in providing interpretation of the information to others.
Preferred knowledge and experience with the regulatory process for
approval of both biologics and small molecule products
Demonstrated ability to work and draft documents in a fast-paced
environment
Flexible with respect to prioritization of daily tasks and projects
according to internal and
external influences
Strong organizational skills and attention to detail
Excellent written and verbal communication skills
Horizon Core Values & Competencies:
Growth
Accountability
Transparency
Horizon Therapeutics plc does not discriminate on the basis of
race, color, religion, gender, sexual orientation, national origin,
age, disability, veteran status, or any other characteristic
protected by law. It is our intention that all qualified
applications are given equal opportunity and that selection
decisions be based on job-related factors. Any individual, who,
because of a disability, needs accommodation or assistance in
completing this application or at any time during the application
process, should contact the Human Resources Department.
Keywords: Horizon Therapeutics, Bethesda , Sr Manager, Regulatory Affairs - Strategy, Executive , Bethesda, Maryland
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