Regulatory, Senior Associate III
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, 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!
Our Commitment to Diversity, Equity, Inclusion and Belonging
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 and represent an important component of our goals and objectives. 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 is grounded in our Values of 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.
The Regulatory Senior Associate III should possess demonstrated skills in the following areas: project management (i.e. document coordination and assigned project leadership), document writing, document revision, interpersonal and written communication. The Senior Associate should also be able to work effectively in a dynamic environment, demonstrate a clear knowledge of regulatory pathways and options, understand the document requirements for regulatory submissions, participate in risk-benefit analysis discussions, be able to effectively communicate strategic decisions internally and externally to appropriate functional areas, and be able to work independently with limited supervision. They have responsibilities for documentation, compliance, submissions, regulatory intelligence, post marketing surveillance/vigilance (as needed), and labeling review. These individuals actively participate in technical/scientific/regulatory activities and discussions, hands-on training to strengthen and develop new skills and knowledge, and are self-motivated. Knowledge of basic statistical approaches to data evaluation basic pharmaceutical manufacturing principles are a plus, but are not required.
The Regulatory Senior Associate III is responsible for
- Coordination, composition, and completion of assigned regulatory projects from initiation to commercialization including INDs, ANDAs, supplements, amendments, annual reports, 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.
- Participate in evaluation and communication of technical issues to project teams
- Participate in Regulatory impact analysis, result communication and implementation of associated change
- Regulatory Intelligence and due diligence
- Participate in development of regulatory timelines and tracking
- Regulatory representation on cross functional teams
- Provide regulatory guidance to project teams and others as appropriate
- Elevation of regulatory issues to regulatory management
- Evaluation of proposed changes for regulatory impact, including approved and proposed applications
- Internal/External communication of regulatory requirements and guidelines, strategic goals and timing
- 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:
- BS or above with 2-4+ years of experience in CMC or labeling and two or more years of applicable US Regulatory Affairs experience. US Regulatory Affairs Professional Certification, IND and NDA experience 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
- Experience working cross functionally
- Excellent verbal and written communication skills
- Availability and willingness to travel as necessary
Necessary Knowledge, Skills and Abilities:
Demonstrated ability to:
- 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
Availability to locally work at one of the following locations:
- Research Triangle, North Carolina
- Coventry, Rhode Island
- Wilson, North Carolina
- Stamford, Connecticut
Supervisory Responsibilities (if applicable):
No direct reports. However, the Senior Associate will work as a liaison for the Regulatory Affairs department on projects. Significant comments or questions regarding submissions and strategies will be discussed with the direct supervisor as needed, but minor issues or questions will be handled by the associate.
Job Titles Supervised:
No direct reports, however, may have responsibilities for contractors or interns where applicable.
Our Company is an Equal Employment Opportunity/Affirmative Action employer, Minority/Female/Disability/Veteran, encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, gender, national origin, religion, color, age, sex, sexual orientation, pregnancy, marital status, gender identity or expression, genetic information, disability, veteran or military status, or any other characteristic protected by local, state, or federal law.
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- Equal Employment Opportunity is the Law (EEO)
- EEO is the Law Poster Supplement
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- Employee Polygraph Protection Act (EPPA)
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- Job Family Medical Affairs
- Pay Type Salary
- Required Education Bachelor’s Degree
- 201 Tresser Blvd, Stamford, CT 06901, USA
- 4701 Purdue Dr, Wilson, NC 27893, USA
- 498 Washington St, Coventry, RI 02816, USA
- Research Triangle, Durham, NC, USA