Asst Mgr. Regulatory Affairs

Asst Mgr. Regulatory Affairs

Leading Pharma

Asst Mgr. Regulatory Affairs

Details of the offer

Job Description:
This role will be part of the Regulatory Affairs department supporting the business through the preparation of product submissions, supplements, license renewals, label reviews, product development team/other cross functional team participation, and other regulatory affairs support activities. This position will interface with key business and cross-functional stakeholders to ensure that the regulatory compliance objectives are achieved.
Role and Responsibilities:
o Preparation, compilation, and submission of high-quality original submissions (ANDAs, Amendments, Supplements, Annual reports, etc. to FDA.
o Preparation and Submission of Controlled Correspondence with FDA.
o Monitoring labeling activities; Preparation, Review and Submission of Labeling in line with RLD or based on internal changes as needed.
o Review of CMC documents like specifications, batch records, process validation and analytical method validation protocols/reports.
o Monitoring of Pharmacopoeial updates.
o Handling of electronic submissions (eCTD) through product life cycle management.
o Perform other related duties as assigned to meet departmental and Company objectives.
o Develop and create submission schedules and work plans for monitoring, compiling and submitting manual and electronic filings that are consistent with company standards. Proactive role in developing and applying new approaches to tracking data and submitting filings.
o Develop functional processes for area managed.
o Interfaces with senior management to report on project and program milestones and to present project needs. Requires the ability to influence others and achieve results.
o Assess impact of new regulations and implement appropriate changes.
o Support the regulatory, formulation development and analytical department: to provide the literature, references for dossier preparation, interpretation of regulatory guidelines and preparation of regulatory strategy for new products.
o Participates in the modification, development and implementation of company policies and practices for regulatory affairs.
o Preparation and Submission of End User Letters.
o Oversee implementation of adverse drug events (ADE) program and submissions of ADEs to FDA per applicable regulations (as needed).
Knowledge, skills and abilities:
o An experienced regulatory strategist with strong technical and interpersonal skills
o Proven negotiation skills and experience in leading interactions with US FDA and other regulatory authorities
o Strong knowledge of regulations, and experience with interpretation and application.
o Demonstrated ability to lead, mentor and develop others for future growth and development
o Established relationships with regulatory authorities
o Excellent communication skills both written and verbal
o Demonstrates strong ability to collaboratively interact and work effectively with other departments as well as external organizations
o Ability to manage assignments that are given in the form of objectives with no process defined.
o Excellent organizational skills, ability to multi-task and with attention to detail: capable of managing multiple projects within assigned timelines.
Qualifications and Education Requirements:
Bachelor?s degree in a scientific related field. Advanced degree preferred.
5+ years of professional experience including 2 years of regulatory experience or 5 years of experience in QA. Generic pharma experience a plus.
Job Type: Full-time
Salary: $65,000.00 to $75,000.00 /year
ind submission: 1 year (Preferred)
management: 1 year (Preferred)
regulatory affairs: 1 year (Preferred)

Work authorization:
United States (Required)

Work Location:
One location

Health insurance
Dental insurance
Vision insurance
Retirement plan
Paid time off

Monday to Friday
8 hour shift

Company's website:

Benefit Conditions:
Waiting period may apply

Work Remotely:

Source: Jobsxl



Operations services associate

Remote, temporary position. Will conduct phone calls, create tickets, handle file procurement, assist with file processing and other tasks as needed. High...

New York

Published a month ago

Software engineer ii, platform

Flexible remote position will develop the platform's core API/associated services, optimize backend solutions for speed/scalability, investigate/implement new...


Published a month ago

Director - equity investments

Full-time job, remote option.Pays $107,555 a year.Needs bachelor's degree and seven years' direct and progressive experience. in investment management. conduct...


Published a month ago

Mortgage operations associate

Temporary remote position will assist with file procurement/ticket creation for file processing, assist with processing tax amounts in the internal system, and...


Published a month ago