Senior Executive - Regulatory Affairs (CMC Expert)

Job Description

About your role

We have vacancy for CMC expert role in Regulatory Affairs team. We are looking for Executive/Sr. Executive. This individual will be based in Mumbai. 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 according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work)
• 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

• 5 - 8 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 & please share below details,

• Required documents, CV/Resume
• Current CTC, Expected CTC & Notice Period.
• Application deadline - 30.06.2025
  
  

About Us

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

Orion provides meaningful work for more than 3 600 Orionees in Finland and abroad. Orion is known as a responsible and reliable employer where we value each other, strive for the best and build for tomorrow.

We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others.