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

Open nowFirst seen 6 days ago

Regulatory Affairs Specialist-Romania

innovaderm/15.00395 open roles

Where
Romania, Remote
Work mode
Remote
Get the CV for this job

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

Your applicationOpen nowRegulatory Affairs Specialist-Romaniainnovaderm/15.003 · Romania, Remote

  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 innovaderm/15.003'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.

12.3% of postings close within 7 days. Measured by our own scanner across the market. innovaderm/15.003 postings stay open a median of 5 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.7%14 days
  5. 35.6%30 days
  6. 58.0%60 days
This job: first seen 6 days ago

innovaderm/15.003 median: 5 days open

The posting

Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual timelines are met. You will provide leadership for assigned projects regarding all regulatory activities that lead to start up of clinical trials.

Responsibilities:

  • Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards
  • Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions. Includes oversight of EU (mainly), APAC, and North America submissions.
  • Review of regulatory documents and submissions created outside of the company by subcontractors (eg, partner CROs, regulatory vendors) to ensure high quality standards before submission to CTIS
  • Point of contact for Sponsors and subcontractors/project management teams for all aspects related to study regulatory submissions
  • Preparation or review of country specific Patient Information Sheet/Informed Consent form documents.
  • Preparation or review of study-specific templates of regulatory forms.
  • Manages translation requests with vendor.
  • Regulatory support and advice to project teams and key internal/external customers on local requirements and EU submission strategy and technical expertise
  • Maintain high level knowledge about EU CTR and EU/EEA countries local requirements in the area of company interest.
  • Maintain the regulatory intelligence database
  • Participation in Kick-off meetings, audits, and other project related meetings according to the company / client needs

Requirements

Education

  • Bachelor's degree (or equivalent) in a scientific discipline

Experience

  • Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working in Romania regulatory affairs is required
  • Experience in initial CTA is essential
  • Experience in a sponsor facing role is an asset
  • Previous experience with CTIS is an asset
  • Hands-on experience preparing, reviewing, and submitting regulatory documentations

Knowledge and skills

  • Excellent knowledge of applicable EU regional / national country regulatory guidelines (such as Poland, Spain, Germany, France, Netherlands)
  • Excellent knowledge of GCP and ICH standards
  • Fluency in English with excellent oral and written skills, required
  • Additional languages represent an asset
  • Excellent organization and communication skills, great attention to detail
  • Ability to organize own work, prioritize different assignments, and work under pressure;
  • Versatile and comfortable in a multitasking environment;
  • Respect established timelines, expectations, priorities, and objectives;

Our company

The work environment

At Indero, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

As a Regulatory Affairs Specialist you will be eligible for the following perks:

  • Permanent full-time position
  • Flexible schedule
  • Vacation
  • Home-based position
  • Ongoing learning and development

About Indero

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale..

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Romania.

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 innovaderm/15.003'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 innovaderm/15.003'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

    innovaderm/15.003'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.