Senior Regulatory Affairs Associate
**Please do not apply if you would need to relocate to get to the job. Work location can be either Levittown, PA or Basking Ridge, NJ**
**MUST have previous Regulatory Affairs experience**
Responsible for managing and guaranteeing the processes of maintenance and registration of new products and state wholesaler licenses as required from the FDA (Food and Drug Administration) and other regulatory agencies. Submit electronic documentation through ESG ( (Electronic Submissions Gateway).
· Provide strategic regulatory support to all functional groups.
· Create, organize and manage the preparation of all types of FDA submissions including post approval changes and PLAIRs.
· Preparation and submission of the requisite Annual Reports, and PADERS for approved ANDA’s.
· Respond to queries from FDA.
· Develop a strong relationship with the FDA.
· Advise the Company on relevant new and existing regulatory strategies, risks and compliance requirements and provide regulatory expertise, advice and support for ANDA, NDA 505(b)(2) submissions.
· Assess project risks, and where appropriate, recommend possible contingency plans, and strategies to management in order to mitigate regulatory risks
· Assess and justify the appropriate category for post-approval change classifications.
· Advise the team on bioequivalence/clinical strategies for more complex generic formulations.
· Independently review and provide feedback to the marketing and business development team. Provide regulatory input on selection of products for development
· Foster collaborative, efficient and effective working relationships with internal team in India and the US.
· Provide guidance, advice and training to junior staff members.
· Monitor and communicate new regulatory requirements and/or review trends to affected
· functional areas such as R&D, Quality, Operations, Sales and Marketing
· Responsible for implementing life-cycle remediation techniques and creating baseline submissions for applications with damaged eCTD life-cycles. Other responsibilities include sANDA Applications, Annual Reports, and Annual/Quarterly PADERs.[SG1]
· Biannually re-certify all drug listings in accordance with 21 CFR 207.57 as well as submission of FDA Establishment Registrations and GDUFA Self-Identifications. Responsible for maintaining all state licenses along with assisting with import clearance.
Desired Skills & Experience
· Experience in submission of and approval of ANDAs and supplements; maintaining approved ANDAs in compliance with guidance to research and operations professional staff.
· Thorough understanding of ICH and FDA guidelines
· Strong understanding of R&D processes required for ANDA submissions.
· Knowledge of regulations/best practices for Rx drug storage/distribution including familiarity with the upcoming track and trace/ePedigreee requirements.
· At least 5 to 7 years of experience in the pharmaceutical industry including 3 plus years regulatory affairs experience in both pre and post approval pharmaceutical FDA submissions.
· Knowledge of filing and approval process for generic drug products.
· Experience in dealing with the FDA – OGD is desirable.
· Experience writing and assembling the supporting documentation for ANDAs and other regulatory filings, including familiarity with CTD format and eCTD submissions.
· Knowledge of product development milestones and compliance requirements.
· Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
· High degree of motivation and initiative are required.
· Proven ability to anticipate challenges and negotiate through them to achieve desired outcome.
· Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
· Excellent communication, verbal and written English skills and ability to/experience of work across cultures and time zones.
· Ability to work successfully within a team/collaborative environment with a high level of professionalism and with the parent company personnel in India.
· Proficient with Adobe, eCTD software and Microsoft Office applications.
[SG1]This is required
Job Type: Full-time
- 401(k) Matching
- Dental Insurance
- Health Insurance
- Paid Time Off
- Vision Insurance
- Monday to Friday
- PLAIRs, Annual Reports, and Periodic safety reports: 2 years (Required)
- eCTD software: 2 years (Required)
- current regulatory guidance (FDA, ICH, and EU): 2 years (Required)
- Pharmaceutical industry: 2 years (Required)
- SOPs: 2 years (Required)
- Regulatory Affairs (ANDA/ 505 (b) (2)): 2 years (Required)
- submissions, registrations, and labeling changes: 2 years (Required)
- Bachelor’s (Required)
- Levittown, PA (Required)
- United States (Required)
- Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status, student visa)?
- Multiple locations
- Temporarily due to COVID-19
To apply, click here
Job posted: 2020-12-30