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

Open nowPosted 4 days ago

Sr. Specialist Regulatory Affairs

Orion38 open roles

Where
Mumbai, India, Hyderabad, India
Work mode
Hybrid
Get the CV for this job

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

Your applicationOpen nowSr. Specialist Regulatory AffairsOrion · Mumbai, India, Hyderabad, India

  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 Orion'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.

13.5% of postings close within 7 days. Measured by our own scanner across the market. Orion postings stay open a median of 15 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.6%3 days
  3. 13.5%7 days
  4. 21.8%14 days
  5. 36.6%30 days
  6. 58.9%60 days
This job: posted 4 days ago

Orion median: 15 days open

The posting

Job Description

About your role

We have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for Specialist/Sr. Specialist. This individual will be based in Mumbai/ Hyderabad. The candidate has the possibility to utilize his/her own strengths with the support of the professionals.

Your key responsibilities

  • Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents and submissions according to EU regulatory requirements.
  • To identify and classify the changes as per EU regulatory variation guidance.
  • To prepare response to regulatory deficiencies letters according to EU regulatory requirements
  • To collaborate with other departments/partners
  • To maintain lists/documents/records
  • Responsible for keeping Orion internal regulatory system up to date and accurate
  • To achieve his/her responsibilities within the agreed timescales
  • To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating
  • Other possible tasks appointed by Supervisors

What we offer

  • An excellent opportunity to work in an inspiring and important role in the area of Regulatory Affairs
  • Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group
  • Possibility to utilize your own strengths with the support of the professionals
  • Flexible, high-spirit working environment where your skills are appreciated
  • Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times).
  • Good work-life balance
  • Clear, transparent processes and responsible supervisors are our benefits to the personnel

At Orion, your work creates true impact and well-being for our customers, patients and society at large. ​ ​Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.

Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/.

Our expectations

Essential competences, education and way of working

  • 7 - 12 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines.
  • Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage.
  • Fluency in oral and written English
  • Ability to work well independently as well as in a team environment
  • Task oriented with learning attitude and Team work skills
  • Familiarity with Microsoft Office

Qualification:

Bachelors / Master degree in Pharmacy or Chemistry from a reputed College / University

How to apply and additional information

Email your CV on [email protected] & please share below details,

- Required documents, CV/Resume

- Current CTC, Expected CTC & Notice Period.

- Application deadline: 15.11.2026

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.

About Orion

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 Orion'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 Orion'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

    Orion'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.