Senior Associate, Regulatory Affairs

Sun Pharmaceutical Industries, Inc.
Croton-on-Hudson, NY
$98K-$119.5K a year
Full-time

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.

15 days ago
Related jobs
Promoted
Sun Pharmaceutical Industries, Inc.
Mahopac, New York

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. Ability to review regulatory and scientific submission documents for ...

Promoted
Sun Pharmaceutical Industries, Inc.
Hawthorne, New York

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. Ability to review regulatory and scientific submission documents ...

Promoted
Regeneron Pharmaceuticals, Inc.
Armonk, New York

CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...

Sun Pharmaceutical Industries, Inc.
Orangeburg, New York

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. Ability to review regulatory and scientific submission documents for ...

SUN PHARMA
Hawthorne, New York

This role is responsible for the preparation of various regulatory Labeling submissions and as well as review of labeling documents for submission. Electronically search for new regulatory guidelines and regulations. Solid review, writing and communication skills and the ability to work independentl...

Sun Pharmaceutical Industries, Inc.
Hawthorne, New York

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. Ability to review regulatory and scientific submission documents for ...

Regeneron Pharmaceuticals, Inc
Tarrytown, New York

Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings with country specific regulatory mentorship documents. The candidate will be leading the regulatory strategies for biologic products ...

Sun Pharmaceutical Industries, Inc.
Hastings-on-Hudson, New York

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. Ability to review regulatory and scientific submission documents for ...

Regeneron Pharmaceuticals, Inc
Tarrytown, New York

Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...

JPMorgan Chase Bank, N.A.
New York, US

As a Compliance - Executive Regulatory Briefings - Senior Associate in our Regulatory Strategy team, you'll have the opportunity assist the department with Executive Briefings and contribute to other reporting needs as time permits. Be able to stay on top of deadlines and drafts, source agenda topic...