Associate Director - Regulatory
Company: Carolina Pharmaceutical Research
Posted on: April 10, 2021
Job Description Job Title: Associate Director Regulatory
Location: Gaithersburg MD 20878 (100% Remote)
Duration: 12 Months
You will be responsible for leading CMC regulatory strategy
development and implementation that incorporates risk
identification and contingency planning for assigned post-approval
and global marketing authorization applications for biologic
products (particularly monoclonal antibodies and/or vaccines). This
role will actively partner with our Manufacturing Operations group
to establish alignment of product regulatory strategies and to
communicate regulatory CMC requirements to team members both
internally and externally. This role also specifically provides
support to internal Reg CMC Commercial Biologics Staff and external
partners who use Client as a contract manufacturing organization.
Activities include Drug Master File submission and maintenance;
submitting information directly to health authorities to protect
Client IP/IK; non-conformance support and assessment; BPDR support
as needed; and other tasks related to supporting Client external
partners (aka 3rd party support). Establishes and develops external
relationships with key Regulatory stakeholders, leveraging these to
maintain competitive advantage. Assess change controls for impact
to DMFs and external partners.
--- Preparation of regulatory submissions, including compilation of
submission documentation, and preparation of regulatory components
(forms, cover letter, etc). The focus of this position is Drug
Master Files for sites and their support of our third party
--- Establishment of submission timelines and management of
information required to meet submission target dates.
--- Responsible for upload, retrieval, and maintenance of documents
for electronic submissions using the appropriate software and
--- Maintenance and filing of regulatory related documentation and
track regulatory commitments, submission requests, timelines, and
--- Research relevant information, regulations, and guidance from
applicable regulatory agencies.
--- Interact with cross-functional groups and attend team meetings
as necessary to support submission development and project
--- Review submission documentation for accuracy and compliance
with applicable regulations and guidelines as required.
--- Proactively identify potential issues and alert supervisor for
Note: This is not necessarily an all-inclusive list of job-related
responsibilities, duties, skills, efforts, requirements or working
conditions. While this is intended to be an accurate reflection of
the current job, SPECTRAFORCE and the assigned client reserve the
right to revise the job or to require that other or different tasks
be performed as assigned.
Pay range: $78- $86 based on experience and skills
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well
as dental, vision, accident, and hospital indemnity insurances.
Additional benefits SPECTRAFORCE offers to the eligible employees
include commuter benefits, 401K plan with matching and a referral
bonus program. SPECTRAFORCE offers unpaid leave as well as paid
sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity
employer and does not discriminate against any employee or
applicant for employment because of race, religion, color, sex,
national origin, age, sexual orientation, gender identity, genetic
information, disability or veteran status, or any other category
protected by applicable federal, state, or local laws. Please
contact Human Resources at
NAhr@spectraforce.com if you require a reasonable
For the full list of our open positions, please check
-- Hi, my name is Avtar Singh
Let me know if you have questions 919-230-9952 Ext 4324
email@example.com Don't see your next job? Submit your
resume anyways and we'll let you know when we find the perfect job
Keywords: Carolina Pharmaceutical Research, Washington DC , Associate Director - Regulatory, Executive , Gaithersburg, DC
Didn't find what you're looking for? Search again!