Senior Associate, Regulatory Affairs
Company: Sun Pharmaceutical Industries, Inc.
Location: Thornwood
Posted on: October 16, 2024
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Job Description:
Responsible for preparing, reviewing and submitting to the
Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE)
and responses to FDA's deficiencies pertaining to submissions. In
addition, Senior Regulatory Affairs Associate is responsible for
supporting a variety of activities in the department related to
regulatory submissions and R&D requests, and supporting other
departments within the organization. Make consistent, sound
regulatory assessments of proposed changes requested by operations
or R&D.
Duties and responsibilities
Responsible for preparation, compilation, review and submission of
new NDAs, ANDAs, DMFs and INDs in eCTD format for FDA submission.
Write related module (Mod 1) in CTD format for NDA, ANDA, DMF and
IND. The submission content, style and architecture should adhere
to electronic common technical document (eCTD) format. Follow
current FDA and ICH guidelines and current cGMP and GLPs,
pharmaceutical product testing requirements. Refer to USP
requirements for chemical, physical and microbiological
testing.
Prepare, and submit INDs, NDAs, ANDAs, DMFs and ANADA annual
reports, amendments and supplements in eCTD compliant format.
Submissions should be prepared and reviewed for accuracy,
consistency, and conformance to FDA and 21CFR regulations, ICH
guidelines and in-house SOPs.
Regulatory support of post-marketing commercial activities. Prepare
and review supplements (PASs, CBE-30 and CBEs) for FDA submission.
Review and approve change control forms for post approval
activities of the product. Utilize regulatory and scientific skills
to evaluate changes (such as changes to an approved product). For
example: container closure system, manufacturing process,
specifications, components and composition, and provide regulatory
assessment based on current FDA and ICH guidelines, 21CFR
regulations, USP requirements (for USP products and APIs).
Evaluate prototype formulations for future filings based on IID
database, RLD labeling, RLD patent(s) and exclusivities.
Prepare Controlled Correspondences for FDA submission based on
information provided by R&D department. The document should be
prepared by utilizing scientific rational and supporting data
provided by R&D department.
Write SOPs.
Maintain database.
Other duties as assigned.
Qualifications
Three to five years of regulatory experience in pharmaceutical
industry is required.
Bachelor's or Master's Degree in a scientific discipline or
equivalent.
Strong written and verbal communication skills necessary.
Ability to review regulatory and scientific submission documents
for accuracy and adherence to regulatory requirements, noting
deficiencies and inconsistencies.
Ability to work effectively in a highly charged, fluid
environment.
Knowledge of Windows based software programs such as Word,
Excel.
Familiarity with FDA website is important in order to accomplish
daily tasks.
The presently-anticipated base compensation pay range for this
position is $98,000 to $119,500. Actual base compensation may vary
based on a number of factors, including but not limited to
geographical location and experience. In addition, this position is
part of the Annual Performance Bonus Plan. Employees are eligible
to participate in Company employee benefit programs which include
medical, dental and vision coverage; life insurance; disability
insurance; 401(k) savings plan; flexible spending accounts; and the
employee assistance program. Employees also receive various paid
time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the
terms and conditions of any governing plans, policies, practices,
agreements, or other materials or documents as in effect from time
to time, including but not limited to terms and conditions
regarding eligibility. If hired, employee will be in an "at-will
position" and the Company reserves the right to modify base salary
(as well as any other discretionary payment or compensation
program) at any time, including for reasons related to individual
performance, Company, or individual department/team performance,
and market factors.
Keywords: Sun Pharmaceutical Industries, Inc., Levittown , Senior Associate, Regulatory Affairs, Other , Thornwood, New York
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