Title:  Senior Associate, Regulatory Affairs

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

1. 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.
2. 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.
3. 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).
4. Evaluate prototype formulations for future filings based on IID database, RLD labeling, RLD patent(s) and exclusivities.
5. 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.
6. Write SOPs.
7. Maintain database.
8. Other duties as assigned.

Qualifications

1. Three to five years of regulatory experience in pharmaceutical industry is required.
2. Bachelor’s or Master’s Degree in a scientific discipline or equivalent.
3. Strong written and verbal communication skills necessary.
4. Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
5. Ability to work effectively in a highly charged, fluid environment.
6. Knowledge of Windows based software programs such as Word, Excel.
7. Familiarity with FDA website is important in order to accomplish daily tasks.