REGULATORY AFFAIRS ASSOCIATE DIRECTOR - US SOLUTIONS, REMOTE
Posted on: June 24, 2022
JOB DESCRIPTIONSummarized Purpose:Provides technical/project
leadership globally, providing innovative solutions including
regulatory expertise and client interface to provide strategic
regulatory intelligence, and guidance for product development from
preclinical through registration and product optimization. Provides
updates to personnel as required on country/regional/global
regulatory intelligence, strategic regulatory authority updates,
and acts as advisers to other units within the department, as well
as any local country regulatory authorities. Acts as liaison with
internal and external clients in the provision and marketing of
these services.Essential Functions:
- Acts as a global lead in providing review and technical advice
to prepare regional and/or global regulatory submissions and ensure
high quality standards that meet or exceed client expectations,
local and regional requirements.
- Acts as lead subject matter expert in providing regulatory
strategy advice and technical expertise to internal and external
clients and oversees key client projects. Provides internal clients
with up-to-date legislation and guidance as it becomes
- Ensures quality performance for key/managed projects.
- Manages project budgeting/forecasting functions.
- Identifies and recognizes out of scope activities in a contract
in a timely manner and liaises with other departments to follow
through on all aspects of contract modifications.
- Collaborates with business development in pricing and securing
new business by making presentations to clients, and develops
proposal texts and budgets in collaboration with other
- Oversees matrix/project leadership, training and guidance to
junior team members.
- Ensures compliance with relevant organizational and department
SOPs and WPDs.
- Participates in and leads launch meetings, review meetings and
project team meetings. Leads departmental initiatives/project
teams.Job QualificationEducation and Experience:
- Bachelor's degree or equivalent and relevant formal academic /
- Previous experience that provides the knowledge, skills, and
abilities to perform the job (comparable to 12+ years).
- Direct experience with pre-approval submissions to the US FDA
including INDs, DSUR, amendments, and others.
- Experience with the duties of US Agent
- Experience with electronic publishing systems and regulatory
- Experience meeting with regulatory authorities in official
- Experience preparing correspondence and responses to US FDAThe
following experiences are highly desirable:
- Experience with marketing submissions
- Experience with post-approval submissions and life cycle
- Experience with vaccines
- Writing experience for orphan drug, fast track and pediatric
plan submissionsIn some cases an equivalency, consisting of a
combination of appropriate education, training and/or directly
related experience, will be considered sufficient for an individual
to meet the requirements of the role.Knowledge, Skills and
- Mastery of English language (written and oral) communication
skills as well as local language where applicable
- Exceptional attention to detail and quality as well as
outstanding editorial/proofreading skills
- Accomplished interpersonal skills to work effectively in a team
environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word,
Excel, Power Point; capable of learning new technologies
- Effective organizational, time management, and planning skills
to create and follow timelines, conduct long-range planning, adapt
to changing priorities and handle multiple projects
- Professional negotiation skills
- Capable of working independently and exercising independent
judgment to assess sponsor regulatory needs and work with project
team members to producing compliant deliverables
- Advanced, broad understanding of global/regional/national
country requirements/regulatory affairs procedures for clinical
trial authorization, licensing, lifecycle management; expert
knowledge of ICH and other global regulatory guidelines; in-depth
understanding of a regulatory speciality areas, such as
preclinical, clinical, CMC, publishing, etc.
- Advanced understanding of medical terminology, statistical
concepts, and guidelines
- Outstanding analytical, investigative and problem-solving
- Excellent understanding of budgeting and forecasting
- Sharp executive presence and consultation and presentation
skillsPPD values the health and wellbeing of our employees. We
support and encourage individuals to create a healthy and balanced
environment where they can thrive. Below is listed the working
environment/requirements for this role:
- Able to communicate, receive, and understand information and
ideas with diverse groups of people in a comprehensible and
- Able to work upright and stationary for typical working
- Ability to use and learn standard office equipment and
technology with proficiency.
- Able to perform successfully under pressure while prioritizing
and handling multiple projects or activities.
- May require travel. (Recruiter will provide more
details.)Diversity StatementPPD is proud to be an affirmative
action employer that values diversity as a strength and fosters an
environment of mutual respect. PPD is committed to providing equal
employment opportunities without regard to age, race, color,
pregnancy, national origin, religion, sex, gender identity, sexual
orientation, disability, veteran status or status within any other
protected group.COVID-19 Vaccination Update for U.S. Colleagues
- All U.S. colleagues are required to report vaccination status.
New hires will be asked to report vaccination status within the
first two weeks of employment.
- All U.S. new hires who are in the following job categories must
be fully vaccinated before their first day of employment or request
an accommodation: executive director level and above, client-facing
commercial, clinical research associates (CRAs), remote site
monitors-local (RSM-L) all CRA and RSM-L line managers,
clinic-based staff in early development services and accelerated
enrollment solutions, and FSP within analytical services division
roles. New hires will be asked to disclose vaccination status upon
first day of employment and are required to report vaccination
status within first two weeks of employment.
Keywords: PPD, Cary , REGULATORY AFFAIRS ASSOCIATE DIRECTOR - US SOLUTIONS, REMOTE, Executive , Morrisville, North Carolina
Didn't find what you're looking for? Search again!