Sr. Specialist Regulatory Affairs

Orion Pharma; Hyderabad; On-site; INR 1,100,000 - 1,600,000; Full time

Job summary

Orion Pharma is seeking a Global Regulatory Expert (Specialist/Sr. Specialist) for its Regulatory Affairs team. The position, based in Mumbai/Hyderabad, offers opportunities to apply EU regulatory knowledge and collaborate with cross-functional teams to manage dossiers, variations, and renewals.

The role emphasizes independent work, strong English communication, and the development of regulatory skills within a dynamic, global pharma environment.

Qualifications

• 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.

Responsibilities

• Prepare/check/review pharmaceutical/quality parts of registration dossiers and variations per EU regulatory requirements.
• Identify and classify changes as per EU regulatory variation guidance.
• Prepare responses to regulatory deficiency letters per EU requirements.
• Collaborate with other departments/partners.
• Maintain lists/documents/records.
• Keep Orion internal regulatory system up to date and accurate.
• Meet agreed timescales for responsibilities.
• Develop regulatory skills within the team through ongoing updating.
• Take on other tasks assigned by Supervisors.

Skills

Fluency in English

Independent work

Teamwork

Task oriented

Education

Bachelor's or Master's in Pharmacy or Chemistry

Tools

Microsoft Office

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.

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' 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

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.