Senior Associate, Regulatory Affairs
Company: Sun Pharmaceutical Industries, Inc.
Location: Hawthorne
Posted on: October 22, 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 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., Greenwich , Senior Associate, Regulatory Affairs, Other , Hawthorne, Connecticut
Didn't find what you're looking for? Search again!
Loading more jobs...