Senior Regulatory Affairs Associate - Purdue Pharma L.P. : Job Details

Rhodes Pharmaceuticals L.P. has developed and distributed quality pharmaceutical products nationwide since 2008. With our R&D capabilities, industry partnerships, broad customer base, and strong relationships with suppliers, we offer reliable supply of high-quality products at competitive prices. At Rhodes Pharmaceuticals L.P., you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We welcome the opportunity to have you on our team! We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines. Diversity, Equity, Inclusion and Belonging are important to our business and are articulated in our People and Culture strategy, as well as our work. As we build an exciting path forward, we strive to create an environment where everyone can bring their best and true self to work each day. Embracing different backgrounds, ideas, and viewpoints are valued and encouraged. We believe that Respect grounds in our Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other. Together we make an impact on our growth, our culture, and most importantly, patients.Job Summary:The Senior Regulatory Affairs Associate supports the Regulatory Affairs team with document submission, document writing, document revision, and completion of other assigned regulatory projects from initiation to commercialization. The position has responsibilities for documentation, compliance, submissions, regulatory intelligence, post marketing surveillance/vigilance, and labeling review.The Senior Regulatory Affairs Associate works effectively in a dynamic cross-functional environment, demonstrate a clear knowledge of regulatory pathways and options, understand the document requirements for regulatory submissions, help drive risk-benefit analysis discussions, and be able to effectively communicate strategic decisions internally and externally to appropriate functional areas. Actively participates in technical/scientific/regulatory activities and hands-on training to strengthen and develop new skills and knowledge. Primary Responsibilities: The Senior Regulatory Affairs Associate is responsible for:

• Coordination, composition, and completion of assigned regulatory projects from initiation to commercialization including INDs, ANDAs, supplements, amendments, annual reports (as needed), periodic adverse event reports, and SOPs
• Review and revision of regulatory documentation, including labeling, CMC documents and reports
• Electronic rendering and publishing of regulatory submissions
• Evaluation and communication of technical issues to project teams
• Evaluate Regulatory impact, communicate to project teams, and implement associated changes
• Regulatory Intelligence and due diligence
• Lead Regulatory discussions as part of the cross functional teams as needed
• Participate in development of regulatory timelines and tracking
• Regulatory representation on cross functional teams
• Provide regulatory guidance to project teams and others as appropriate
• Elevate regulatory issues to regulatory management
• Internal/External communication of regulatory requirements and guidelines, strategic goals and timing
• Evaluation of proposed changes for regulatory impact, including approved and proposed applications
• Communication with contract organizations, outside regulatory consultants, various internal departments, and contacts from associated companies for assigned projects
• Other tasks as assigned

Education and Experience:

• A Bachelor's degree or above with 2 - 5+ years of experience in CMC or labeling and minimum 2 years' experience in US Regulatory Affairs
• US Regulatory Affairs Professional Certification is preferred
• Experience preparing and filing electronic CTD submissions in the US
• Experience with regulatory timeline development and tracking
• Experience with peer and technical document review
• Regulatory Intelligence and Impact analysis
• Excellent verbal and written communication skills
• Availability and willingness to travel as necessary

Necessary Knowledge, Skills and Abilities:

• Communicate effectively verbally and in writing
• Think analytically and critically
• Accurately review and analyze documentation
• Handle detailed tasks and prioritize them
• Meet deadlines and track regulatory requirements and submission targets
• Work effectively in a team environment
• Embrace change and openly discuss ideas
• Take ownership of assignments and seek innovative ideas and solutions
• Analyze and integrate information from diverse backgrounds
• Work with others from diverse backgrounds
• Ability to work independently and adapt to changing priorities
• Negotiate with internal stakeholders and project teams
• Knowledge of basic statistical approaches to data evaluation basic pharmaceutical manufacturing principles are a plus

Supervisory Responsibilities (if applicable)There are no direct supervisory responsibilities.Physical/EnvironmentalPerform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax or other specialized equipment used in an office setting.Additional InformationThe job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.The position is a Remote-Based role, however candidate must reside in NC. Relocation is not offered for this position. Purdue Pharma does not sponsor or facilitate any U.S. work/intern or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at Purdue Pharma. We respect diversity and accordingly are an equal opportunity and an affirmative action employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance. For more information about your rights under Equal Employment Opportunity, visit:

• Equal Employment Opportunity is the Law (EEO)
• EEO is the Law Poster Supplement
• USERRA Rights
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act (EPPA)
• E-Verify (English and Spanish)
• Right to Work (English and Spanish)
• Pay Transparency Nondiscrimination Provision (English)
• Pay Transparency Nondiscrimination Provision (Spanish)

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• The Company never requests money or fees for any purpose during or after the hiring process.
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• The Talent Acquisition team does not request or require personal documents like bank account details, or credit card information as part of the recruitment process.

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