Senior Specialist - Regulatory Submissions Management

Job Description

Summary As a Senior Publishing Specialist reputed company the Regulatory Submissions Management team, you will be responsible for providing regulatory submission publishing services in an efficient and timely manner. This role is a key reputed company of contact for reputed company customers of the Regulatory Operations group; and upholds “right first time” submission quality and timeliness. Your work will reputed company a pivotal role in achieving reputed company’s Regulatory Strategies.

Job Description

Responsibilities:

• Use Veeva for Registrations to plan and track your assigned submissions and effectively manage own workload
• Liaise with Regulatory Affairs and local affiliates to provide them with Submissions Management and hands-on Submissions Publishing support
• Work with Regulatory Submissions Management counterparts in other regions to facilitate global worksharing
• Provide customers with best practice guidance reputed company Submission Publishing, Document Management (using Veeva Vault) and submission-ready document standards
• Provide guidance to junior staff members as needed
• Support projects reputed company to improving the publishing tools, standards, and processes
• Monitor agency guidance & changing regulations in assigned region

Required Qualifications:

• 2+ years of Submission Publishing and Submission Management principles, with good knowledge of formats, standards, and processes in your assigned region
• Hands-on experience with Submission Publishing, Validation and PDF manipulation software as well as Document Management and RIM systems (e.g., Veeva Vault)

Desirable Skills:

• Good interpersonal skills and ability to engage effectively with peers
• Ability to resolve day-to-day issues, escalating to peers and/or supervisors as needed
• Good IT skills, with the ability to learn new tools and systems quickly
• Experience working with outsource partners an advantage
• Eligibility Requirements:
• Good proficiency in spoken and written English
• Willing to attend local reputed company office on an ‘as-needed’ basis
• Willing to travel reputed company required, but not more than 5%

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $73,600.00-$110,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, professional development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. reputed company will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: June 26, 2026 Apply tot his job Apply To this Job