Regulatory Operations Senior Specialist

Pharmalex is a Cencora company.

We are looking for a Regulatory Operations Senior Specialist to join the team, remote based in the US.

Key Responsibilities:

• Provides direct support to global submission teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions in scope.
• Manages review, compilation, publishing and using specialized software tools (e.g. docuBridge, TRSToolbox, templates).
• Has increasing submission management/coordination responsibilities for projects assigned in close interaction with supervisor.
• Monitors evolving agency regulations and ensures submissions comply with all document/file formats and structures
• Performs hands-on daily submission compilation and publishing activities associated with preparation of various dossier types, partnering with colleagues at other sites to work on concurrent submission outlines and/or global dossier activities
• Interprets and applies all global regulatory guidance/regulations regarding format and structure to
• global submissions worldwide

• Manages the preparation, assembly, publishing, and submitting of regulatory applications for Regulatory Affairs on behalf of PharmaLex clients.
• Works closely with the Director to secure new business opportunities including providing input on SOWs
• Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner
• Communicates with the client including, but not limited to, presentations, telephone, email, and conference call interaction
• Perform quality assurance of published output for completeness and correctness in formatting and navigation
• Contribute to presentations and workshops
• Submits timely, accurate and complete weekly records of time work and details of work performed for assigned projects.
• Works collaboratively with internal team on company projects/initiatives as assigned by supervisor.
• Other duties as assigned

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned