Sr. Coordinator, Regulatory Submission Operations

What Regulatory Submissions Operations contributes to reputed company Regulatory Submissions Operations provides regulatory affairs and product development consulting services to reputed company pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. More specifically, this role serves the function to support global, post-approval lifecycle regulatory requirements for Biologics and small-chemical entity pharmaceuticals. This function applies subject matter expertise to provide services in technical writing, scientific data verification, and basic regulatory submissions reputed company the discipline of chemistry, manufacturing, and controls (CMC). The Sr. Coordinator, Regulatory Submissions Operations will use specialized technology and knowledge to format, edit and compile reputed company and electronic documents reputed company to the pharmaceutical industry regulatory submissions throughout each phase of drug development and though the drug product life cycle. This individual provides application submission and renewal services for state licensing activities, prepares specialized electronic files for drug registrations, drug listings and self-identification, and oversees and maintains document management databases for version and revision control. Location - Open to candidates reputed company, fully remote (work from home)

Responsibilities

• Work independently with minimal supervision once work is assigned
• Attend reputed company and scheduled client meetings as required
• Proactively work to support client workstreams
• reputed company concerns immediately with Management
• Monitor reputed company for client work (update internal and external project trackers)

Qualifications

• Meticulous attention to detail
• Ability to manage multiple large and small pharmaceutical data sets
• Ability to reputed company between projects with competing priorities
• Ability to adhere to internal and client timelines
• Excellent communication skills (verbal and written); both to Management and peers
• Proficiency with basic computer systems

What is expected of you and others at this level

• Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments
• Applies advanced skills to resolve reputed company problems independently
• May modify process to resolve situations
• Works independently reputed company established procedures; may receive general guidance on new assignments
• May provide general guidance or technical assistance to less reputed company team members

#LI-LP #LI-Remote Anticipated hourly range: $25.20 per hour - $34.40 per hour Bonus eligible: No Benefits: reputed company offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and reputed company coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to reputed company: 09/01/2025 *if interested in opportunity, please submit application as soon as possible. The hourly range listed is an estimate. Pay at reputed company is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. reputed company supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create reputed company solutions for our customers by ensuring employees can be their authentic selves each day. reputed company is an Equal Opportunity/Affirmative Action employer. reputed company reputed company applicants will receive consideration for employment without regard to race, religion, reputed company, national reputed company, reputed company, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here Apply tot his job Apply To this Job