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Regulatory Affairs Associate/Senior Associate

Company: Alvogen
Location: Pine Brook
Posted on: March 29, 2020

Job Description:

SUMMARY OF POSITIONIndependently prepares reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include Annual Reports, amendments, ANDA's and supplements to ANDAs or NDAs. Gives input to established objectives and goals. Applies advanced knowledge of the pharmaceutical development cycle. Provides guidance to teams and peers to achieve goals. Administers and recommends changes to policies and procedures as applicable. Coaches and mentors junior team members.

Works on and solves increasingly complex projects/problems where analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within defined procedures and policies to determine appropriate action. Represents Regulatory Affairs perspective to teams/team members to meet schedules and/or resolve technical problems.

Quality/Productivity of work will assist in achieving team, departmental and company goals in timely manner. Represent Regulatory Affairs in project teams and provide regulatory guidance to R&D and Operation teams as appropriate.
ORGANIZATION STRUCTURE
The Senior Regulatory Affairs Associate position reports to the Associate Director of Regulatory Affairs.
RESPONSIBILITIESPrimary responsibilities of this role include the following:

1. Authors and prepares original ANDA's/NDA's and amendments in electronic format for submission to the USFDA

2. Liaise and orchestrate meetings with cross functional departments; strategize and plan for timely submissions

3. With supervision, prepares responses to questions (Information Requests and Complete Response letters)from the USFDA

4. Participates in product team meetings (development and marketed products); provides regulatory support and guidance and manages day-to-day regulatory activities

5. Reviews technical documents for submission in new ANDAs, NDAs and provides guidance to the technical development groups.

6. Reviews change control requests for completeness and accuracy; assess impact of change with regards to the approved ANDAs and NDAs

7. Under some guidance, formulate strategies to maintain submission goals

8. Prepares supplements to support post approval changes and annual reports for approved ANDAs and NDAs.
QUALIFICATIONS
-- Minimum of a Bachelor's degree in a science related discipline.

-- 3-5 years in the pharmaceutical industry with 3 years of Regulatory Affairs experience

-- Exhibit strong knowledge of current CMC and ANDA related regulations/guidance's

-- Ability to liaise and interact with R&D team members

-- Ability to manage timelines

-- Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.
GMP DECISION-MAKING AUTHORITYResponsible for approval of GMP CMC documentation for ANDAs and NDAs. Responsible for the approval of change controls and creation of change controls as necessary.

Keywords: Alvogen, New York , Regulatory Affairs Associate/Senior Associate, Other , Pine Brook, New York

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