Global Regulatory Operations Senior Associate

TITLE: Global Regulatory Operations Senior Associate Title: Global Regulatory Operations Senior Associate Reports To: Global Regulatory Operations Manager Location: Richmond, Virginia Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction – a chronic relapsing disease. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction – including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia. POSITION SUMMARY: The Global Regulatory Operations (GRO) department is organized to provide electronic and paper submission planning, development and publishing support to project teams and the regulatory group, with cross-functional project responsibility also assigned to the team based on business needs. The Senior Associate will plan, develop, publish, file and maintain regulatory application submissions to North America and Australasia health authorities. This role works on business-critical deadlines within a highly regulated environment. The Senior Associate is expected to provide leadership and expertise in the evolution of standards, processes, and application of technology for the optimal assembly, archiving, and presentation of life cycle submissions. Additionally, this role is responsible for the development and enhancement of selected submission-related processes as well as supporting the implementation of solutions through interaction with other team members and key contributors across cross functional groups. ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following: Respond to queries and provide submission guidance to others. Ensure harmonized operational approach and compliance with local and regional regulatory requirements. Provide training and support as needed to team members on the use of regulatory publishing/review systems and submission publishing procedures. Support utilization of electronic technologies for submissions and tracking of project status. Provide QA/QC support for electronic submission documents (eCTD and NeeS) and deliverables. Work with other Global Regulatory Operations team members, project teams, and submission contributors to ensure appropriate level of understanding in order to support the contribution of submission-ready documents for paper-based and electronic submissions. Participate in the development, refinement, and rollout of internal guidelines, procedures, and processes pertaining to submissions (electronic or paper) building, QC, and processing. Participate in the testing and piloting of new electronic software tools and submission types. Manage projects of moderate complexity and handle high-volume submissions, document processing, and/or archiving. Tasks include those at the Regulatory Operations Associate level, however will be more complex and in greater volume. Anticipate upcoming tasks based on submission deadlines and implementation work. Demonstrate strong project management skills and ability to effectively communicate cross- functionally, as well as a depth of knowledge of ICH and local country requirements. May represent Global Regulatory Operations by taking the lead in submission planning meetings to help define company submission priorities and interface with regulatory product managers and or content authors to provide guidance on submission preparation and content. Responsible for managing and coaching the Global Regulatory Operations Associate (if applicable). Provide periodic updates to Global Regulatory Operations Manager regarding projects status and issues that could impact on target dates should they arise. Remain in touch with latest industry business developments which may impact the Global Regulatory Operations team MINIMUM QUALIFICATIONS Education: Bachelor of Science / Bachelor of Arts or equivalent Field of Study: Sciences (Chemistry, Biology, Pharmacy, etc.) ideal Experience: at least 4 years License/Certifications: Not Applicable Travel: 5% COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Excellent verbal, and written communication skills, strong organizational skills and strong attention to detail and must be able to balance multiple tasks simultaneously to achieve goals. Flexibility to work effectively within an environment with quickly changing processes, priorities, and deadlines. A working knowledge and understanding of MS Word, Word templates, Adobe Acrobat, standard MS Office tools, and ability to master new technical skills and apply them to projects. An advanced knowledge of document management and regulatory publishing. Ability to work independently PREFERRED QUALIFICATIONS: Qualified to degree level with a focus in science or business-related studies and 4 to 6 years of experience in the pharmaceutical or a related industry or other relevant experience. Familiarity with Acrobat-based PDF QC tools (e.g. ISIToolbox). Familiarity with eCTD publishing tools (eCTDXPress, EXTEDO eCTDManager, etc). Strong experience with document management and electronic submissions to regulatory agencies. BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes 3 weeks’ vacation plus floating holidays and sick leave 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health and Dependent Care Flex Spending options Adoption assistance Tuition reimbursement Leverage Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage Gyms, fitness facilities and cell phone discounts Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees. GUIDING PRINCIPLES: Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled