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
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
Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
AuroMedics is a generic injectables company that has built its business and offerings around servicing our customers' needs. Our strategy is to focus on producing excellent products, customizing procurement solutions, and expanding our portfolio into niche and specialized categories. Since inception in 2011, it has been our mission to make buying injectables an experience customers look forward to.
We leverage the vertical integration of our parent company Aurobindo Pharma. This competitive advantage allows us to have more control over the supply chain process compared to many of our competitors. We are proud to offer broad portfolio of high quality injectables predominately utilized in acute care hospital settings as well as outpatient institutions. Our portfolio targets include: in demand, off-patent injectables, ANDA products, and products often found on the FDA drug shortage list.
AuroMedics' major focus is growth expansion of our product line offerings for the upcoming fiscal years. Our goal is to launch one to two products per month, as we continue to anticipate the needs of our growing customer base.