Job Overview

The Associate Director of Regulatory Affairs for AuroMedics/Eugia Specialties will have regulatory accountability across multiple injectable pharmaceutical development programs/therapeutic areas, will manage internal regulatory processes, and will develop regulatory capabilities/competencies within the division. The position manages three (3) direct reports in the United States, as well as a team of indirect reports in India. 

Location: Onsite, East Windsor New Jersey

Responsibilities

• Leads the regulatory activities required to support product development activities and to achieve marketing authorization for Eugia’s specialty business development programs
• This position ensures timely communication, feedback and follows up with the FDA and is responsible for maintaining open communication with Senior Leadership as well as with employees within department
• Communication with the FDA and notifying upper management of FDA correspondence and application status
• Interpreting laws and guidance’s applicable to the development and operations and ensuring that these regulations are rolled out within the organization
• Advise internal customers with regulatory strategy and implementation plan for submissions and approved applications
• Oversees review and approval of documents (batch records, specifications, analytical methods, protocols etc.) for regulatory filings and/or regulatory compliance
• Supervises the preparation of ANDAs, NDAs, and INDs for multiple product types including complex injectables, combination products, and small molecule parenteral products
• Determine strategy to resolve deficiency questions from the Agency and path forward to complete additional activities to support responses
• Review Deficiency response letters and post approval supplements for appropriate wording, terminology, and presentation
• Assemble the regulatory plans for identified projects/products. Influences and imparts broad expertise regarding US regulatory environment. Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects.
• Advise cross functional groups how to prepare filings with particular emphasis on sterility assurance information
• Develop therapeutic regulatory strategies and operational plans for identified pipeline and marketed products. Review/provide counsel on product development plans. This includes recommendations for regulatory strategies for submitting changes
• Ensure continued growth by providing submission strategy for facility and equipment upgrades to meet the business needs
• Supports Executive Management Team with development of technical, IP and regulatory strategies for ANDAs and 505(b)(2) applications

To protect the safety of our workforce, customers, and communities, the policy of the Company requires all employees and workers in the U.S. to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  All applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. 

Qualifications - Skills & Requirements

• Prior experience leading and managing a team - onsite and remote
• Ability to influence others by presenting alternative options persuasively
• Must be able to innovate, analyze and solve critical/complex business problems
• Thorough knowledge of the drug research, development, and commercialization process
• Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Must be able to innovate, analyze and solve critical/complex business problems.
• Strong project management skills with the ability to plan, organize, and multitask
• Strategizing abilities especially as it pertains to the regulatory requirements for complex filings
• Effective Problem-Solving, Clear Communication, Highly Proactive, Decisive with Strong Interpersonal Skills, Strategic, Commitment to Timelines
• Ability to work in the United States without requiring sponsorship

Education and Experience

• Bachelor’s Degree in a scientific or technical field such as (chemistry, biology, pharmaceutics, etc.)
• Must possess minimum of seven (7) years of applicable Regulatory Affairs experience that includes filing applications to regulatory agencies; or a combination of relevant pharmaceutical manufacturing facility experience preferably in production, quality control, compliance/assurance, or R & D and at least five (5) years regulatory experience

We Are An Equal Opportunity Employer