Sr. Specialist Regulatory Affairs

Orion Corporation; Mumbai; Hybrid; INR 1,800,000 - 2,400,000; Full time

Benefits offered by this job

Hybrid work policy

Good work-life balance

Transparent processes and supportive:0

Job summary

Orion Pharma is seeking a Global Regulatory Expert (Specialist/Sr. Specialist) to be based in Mumbai/Hyderabad. You will handle EU regulatory dossiers, ensure compliance with ICH guidelines, and coordinate with cross-functional teams in a hybrid work setup.

The role requires 7–12 years in international regulatory affairs, strong English, and a track record in submissions and regulatory responses. Join us to drive regulatory excellence within a supportive global organization.

Qualifications

• 7–12 years of international regulatory affairs in pharma.
• Knowledge of EU requirements and ICH guidelines.
• Fluency in English (oral and written).
• Ability to work independently and in a team.
• Task-oriented with learning attitude and teamwork.
• Familiarity with Microsoft Office.

Responsibilities

• Prepare, check, and review regulatory dossiers and variations per EU requirements.
• Identify and classify changes per EU variation guidance.
• Prepare responses to deficiency letters per EU requirements.
• Collaborate with other departments and partners.
• Maintain Orion internal regulatory system up to date.
• Meet agreed timelines and manage priorities.
• Contribute to regulatory skills development within the team.
• Perform other tasks assigned by supervisors.

Skills

English fluency

Independent working

Team collaboration

Learning attitude

MS Office

Education

Bachelor’s/Master in Pharmacy or Chemistry

Tools

eCTD submissions

Job description

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
• 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.

Essential competences, education and way of working

• 7 - 12 years' workexperience 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

- Current CTC, Expected CTC & Notice Period.

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.