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Associate Director - Regulatory

Company: Carolina Pharmaceutical Research
Location: Gaithersburg
Posted on: April 10, 2021

Job Description:

Job Description Job Title: Associate Director Regulatory
Location: Gaithersburg MD 20878 (100% Remote)
Duration: 12 Months
Schedule: M-F
--
Job Description:

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.

Responsibilities:
--- 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 users.
--- 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 applications.
--- Maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, timelines, and deliverables.
--- 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 coordination.
--- Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
--- Proactively identify potential issues and alert supervisor for further action.
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 accommodation.
For the full list of our open positions, please check www.spectraforce.com
-- Hi, my name is Avtar Singh
Let me know if you have questions 919-230-9952 Ext 4324
avtar.singh@spectraforce.com Don't see your next job? Submit your resume anyways and we'll let you know when we find the perfect job for you

Keywords: Carolina Pharmaceutical Research, Washington DC , Associate Director - Regulatory, Executive , Gaithersburg, DC

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