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Regulatory Ops Specialist II/Sr Regulatory Ops Spe

at Certara USA, LLC in Wilmington, Delaware, United States

Job Description

At Certara, we accelerate medicines to patients by partnering with life science innovators.

In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:

informed decision-making & reduced clinical trial burden

higher R&D productivity

improved patient outcomes & increased patient access to medicines

accelerated regulatory approval

Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.

Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.

Synchrogenix, a Certara Company: Achieving Regulatory Success

As Certara's Regulatory Science division, Synchrogenix accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Synchrogenix is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are talented, quality-minded, and client and stakeholder-oriented.

Synchrogenix's people are at the core of our success, and our most successful people are:

collaborative and value being part of a team

experts with a thirst for continued learning

consultative with an ability to articulate process and expertise

deadline-driven and able to operate in a fast-paced environment

 

Job Overview:

The Senior Regulatory Submissions Specialist will serve as an internal team leader for electronic submission publishing projects, primarily in eCTD format. He/she will collaborate with colleagues and clients on routine, project related matters. The Senior Regulatory Submissions Specialist will be responsible for proactively completing, and at times, assigning publishing tasks to other team members to meet submission deadlines.

Responsibilities:

Generate and submit SPL files

Proven ability to identify documents that are not eCTD compliant

Possess knowledge of ICH and GXP Guidelines

Technical knowledge of US, CA, and EU eCTD submission requirements

Education, Experience, Training, and Knowledge:

Bachelor's degree or equivalent experience

Strong computer skills, including proficiency with MS Office and Microsoft Word functionality in terms of formatting document using content templates or MS Word styles

Technical knowledge of US, CA and EU eCTD submission requirements

Regulatory Ops Specialist II:

2-4 years of prior experience using software applications including eCTD publishing, Adobe Acrobat and MS Office working in a professional environment that demands high utilization of computer and communication skills

Sr. Regulatory Ops Specialist:

4-6+ years of prior experience using software applications including eCTD publishing, Adobe Acrobat and MS Office working in a professional environment that demands high utilization of computer and communication skills

 

Skills & Abilities:

Excellent IT/computer skills

Excellent written and verbal communication skills

Work in a role that demands strong attention to detail and organizational skills in a fast-paced environment

Proven ability to identify documents that are not eCTD compliant

Demonstrate solid time management skills

Organized, efficient, flexible, self-motivated

Show flexibility to meet project needs as required by deadlines and meet corporate goals and objectives

Remain knowledgeable of changes in the industry and adapt best practices

Maintains high ethical and quality standards as defined in the Employee Manual

 

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

 

#LI-HM

 

Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.        

 

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Job Posting: 860003

Posted On: Oct 19, 2021

Updated On: Nov 01, 2021