Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 3823 days ago

Regulatory Affairs Specialist

Artech Information System LLC1,272 open roles

Where
Cambridge, MA, United States
Work mode
On site
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowRegulatory Affairs SpecialistArtech Information System LLC · Cambridge, MA, United States

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Artech Information System LLC's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.7% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.7%7 days
  4. 20.4%14 days
  5. 35.6%30 days
  6. 58.7%60 days
This job: posted 3823 days ago

The posting

Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

• The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the regulatory community. The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. The role works to tight, business-critical deadlines within a highly regulated environment.

• She/he also ensures that compliance standards are met for receipt and delivery of information to and from external consultants and health authorities.

• Expert in publishing capabilities of all modules with a competency in the component locations within the eCTD backbone structure.

• Support Global Regulatory Leads in the planning, development, and publishing of submissions.

• Control submission component receipt and workflow completion to ensure a high quality final submission. Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.

• Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers.

• Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch.

• Dispatch submissions through the FDA Gateway

• Ensure adherence to internal and external standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application.

• Archive submissions both electronic and paper.

Skills:

• Proficient in use of MS Office, Adobe Professional, Adobe Add-ins, Publishing Software (sCubed and/or eCTD Manager), Validation Tools and Document Management Systems.

• Demonstrate ability to function autonomously in a matrix environment.

• Knowledgeable in appropriate ICH and FDA regulations pertaining to regulatory and technical requirements for electronic submissions.

• Must be detail oriented and articulate with strong analytical, decision-making, and interpersonal

• Demonstrate regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor.

• Demonstrate flexibility in dealing with change and diversity.

• Ability to multi-task in a fast paced environment.

• All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes.

• Proficient in formatting Word documents prior to publishing and electronic navigation for Adobe documents.

Education:

At least a bachelor s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience. Four years submission publishing experience.

Additional Information

Best Regards,

Anuj Mehta

973-967-3402

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Artech Information System LLC's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Artech Information System LLC's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Artech Information System LLC's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.