SENIOR ASSOCIATE, REGULATORY AFFAIRS - SUN PHARMACEUTICAL INDUSTRIES, INC.
Company: Sun Pharmaceutical Industries, Inc.
Location: Mamaroneck
Posted on: October 20, 2024
|
|
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 responsibilitiesResponsible 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.QualificationsThree 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., Bayonne , SENIOR ASSOCIATE, REGULATORY AFFAIRS - SUN PHARMACEUTICAL INDUSTRIES, INC., Healthcare , Mamaroneck, New Jersey
Click
here to apply!
|