Job Description About your role We have vacancy for CMC expert role in Regulatory Affairs team. We are looking for 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 in Vness, CTD and eCTD format according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work) To prepare responses to the quality part of regulatory deficiencies letters according to EU regulatory requirements To collaborate with other departments/CMO-partners To maintain lists/documents/records Responsible for keeping Orion and V.M.D. internal regulatory system current and accurate, especially regarding CMC documents. To achieve his/her responsibilities within the agreed timescales To actively participate in the development of regulatory skills within the regulatory team. Keep up to date with new CMC-related guidelines. 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 3 - 6 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 recruitmentindia@orion.fi & please share below details, Required documents, CV/Resume Current CTC, Expected CTC & Notice Period. Application deadline - 15.05.2025 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. Show more Show less

Job Description Your key responsibilities The Main responsibility of the role is to ensure availability of finished pharmaceuticals products from external manufacturers at the right time with appropriate inventory management as per agreed target. Overall Supplier Management Responsibility for operational task: Securing service level and optimal stock level and updating of weekly stock adequacy list Responsibility for operative purchasing process flow for certain suppliers Forecast updates Orders (purchase orders, re-scheduling and stock transfers) Delivery follow-up with supplier Invoicing process Logistics and EU re-analysis coordination To be main point of contact for operative tasks both towards the supplier and internally within Orion: Participation in internal cross-functional meetings related to operative purchasing issues Providing timely information internally regarding product availability Supporting the Manager responsible for Supplier and category management and development Maintaining and updating (when necessary) SAP product information for purchased products What We Offer An excellent opportunity to work in an inspiring & important role in the area of Supplier Management 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 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 Primary Skills 7 - 8 years’ experience in Purchasing and Inventory management of finished formulations in Pharmaceutical industry preferably EU / US markets Knowledge of EU requirements and ICH guidelines is desired Experience of working in ERP/SAP Task oriented with learning attitude Ability to work in team and flexibility to adapt to change Excellent English communication skills (both verbal & written). Good Interpersonal Skills. Logical and analytical ability Proactive with a desire to learn Proficient in Microsoft Office 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. Show more Show less

Job Description Roles & Responsibilities Executive - Logistics will take the lead in managing the order and delivery process within export logistics. Responsibilities include overseeing the entire export delivery process, efficiently handling order processing, coordinating transportation logistics for export consignments, and maintaining effective communication and customer relations related to orders and deliveries. Collaboration is key, and will be working closely with internal departments (sales, warehouse) and external partners (freight forwarding agencies) to ensure the seamless operation of our logistics activities The Responsibilities Of The Role Are Manage the entire export delivery process. Handle order processing with efficiency and accuracy. Organize transportation logistics for export consignments. Maintain effective communication and customer relations related to orders and deliveries. Collaborate closely with internal departments (sales, warehouse) and external partners (freight forwarding agencies) to ensure smooth operations Primary Skills Minimum 3 - 5 years experience in managing the order and delivery process within export logistics. Experience of working in SAP / ERP is a must Knowledge of EU requirements and ICH guidelines is desired Proven experience in export trade coordination or related roles. Excellent organizational and multitasking abilities. Proficiency in communication and negotiation skills. Ability to work collaboratively with internal and external stakeholders. Excellent English communication skills (both verbal & written) and Good Interpersonal Skills. Task oriented with learning attitude Proficient in Microsoft Office Education - Bachelors / Masters degree from a reputed College / University How To Apply And Additional Information Email your CV on recruitmentindia@orion.fi & please share below details, Required documents, CV/Resume Current CTC, Expected CTC & Notice Period. Application deadline - 31.03.2025 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. Show more Show less

Job Description Job Description and Responsibilities Reviewing packaging activity at CMO site Handling of Computerized Training Management system related activities Handling of Change Request Forms through Computerized software Preparation and Review of Certificate of Analysis (CoA) Analytical Result entries to SAP batch data Maintenance of SOPs and Internal guidelines in SAP Handling of GMP/ MIA certificate availability activity Managing various Quality Assurance documents and notifications Preparation of Report for QA activities Primary Skills (essential) 4 - 5 years’ experience in Quality Assurance (preferably Pharmaceuticals)/ IPQA (Packaging) Experience in managing various Quality Assurance documents and notifications Proficient in MS Office Experience of working in ERP / SAP and computerized systems like Track wise/ DMS would be an added advantage Good English communication skills (both verbal & written) Good Interpersonal Skills Ability to work in team and flexibility to adapt to change Education Bachelors/ Master's degree in Pharmacy / Science from a reputed College / University 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. Show more Show less

Job Description and Responsibilities Reviewing packaging activity at CMO site Handling of Computerized Training Management system related activities Handling of Change Request Forms through Computerized software Preparation and Review of Certificate of Analysis (CoA) Analytical Result entries to SAP batch data Maintenance of SOPs and Internal guidelines in SAP Handling of GMP/ MIA certificate availability activity Managing various Quality Assurance documents and notifications Preparation of Report for QA activities Primary Skills (essential) 4 - 5 years experience in Quality Assurance (preferably Pharmaceuticals)/ IPQA (Packaging) Experience in managing various Quality Assurance documents and notifications Proficient in MS Office Experience of working in ERP / SAP and computerized systems like Track wise/ DMS would be an added advantage Good English communication skills (both verbal & written) Good Interpersonal Skills Ability to work in team and flexibility to adapt to change Education Bachelors/ Masters degree in Pharmacy / Science from a reputed College / University

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 in CTD and eCTD format according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work) 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 recruitmentindia@orion.fi & please share below details, - Required documents, CV/Resume - Current CTC, Expected CTC & Notice Period. - Application deadline - 30.06.2025

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 in CTD and eCTD format according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work) 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 recruitmentindia@orion.fi & 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. Show more Show less

Job Description Roles and Responsibilities Coordinate and follow-up with internal and external partner to review and evaluate Nitrosamine impurity and ensuring compliance to relevant guidelines. Managing and developing the process for Excipient GMP risk evaluation including maintenance of the structure with functionalities. Review elemental impurities statement, its impact on final product and ensuring compliance. Responsible for planning stability studies, writing and/or review of stability protocols, reports and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents and troubleshooting etc. for externally supplied products. Write documents into Orion’s IT systems for example analytical methods Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to PQRs. Requesting, follow-up and tracking of PQR related data. Review of Externally supplied PQRs, related coordination and follow up with vendor and and other stakeholders Theoretical evaluation of physico-chemical properties of the drug products and/or raw materials Co-operation with other departments/ partners Local in-licensing support To assist the overall working of Indian Pharmaceutical team Other possible tasks appointed by Supervisors Note: We do not have own laboratories in India! Primary Skills (Essential) Minimum 4 years' work experience in Analytical Development or Pharmaceutical product development or Quality Assurance activities in global Pharma industry Knowledge of EU and US requirements and ICH guidelines Practical development skills from the laboratory work and troubleshooting Task oriented with learning attitude and Teamwork skills Fluency in oral and written English Confirmed skills of Microsoft Office is essential Pharmaceutical education & practical analytical development skills also from the laboratory to production scale of different types of formulations (tablets, capsules, liquids, etc.) will have added advantage Candidate interested/experienced in above documentation work will be preferred. This Job offers An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals 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 Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel Education Master's degree in chemistry from a reputed College / University 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/ . How To Apply And Additional Information Please fill Candidate Information Form on https://forms.gle/o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi Required documents: CV/Resume Application deadline: 05.07.2025 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. Show more Show less

Roles and Responsibilities Coordinate and follow-up with internal and external partner to review and evaluate Nitrosamine impurity and ensuring compliance to relevant guidelines. Managing and developing the process for Excipient GMP risk evaluation including maintenance of the structure with functionalities. Review elemental impurities statement, its impact on final product and ensuring compliance. Responsible for planning stability studies, writing and/or review of stability protocols, reports and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents and troubleshooting etc. for externally supplied products. Write documents into Orion s IT systems for example analytical methods Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to PQRs. Requesting, follow-up and tracking of PQR related data. Review of Externally supplied PQRs, related coordination and follow up with vendor and and other stakeholders Theoretical evaluation of physico-chemical properties of the drug products and/or raw materials Co-operation with other departments/ partners Local in-licensing support To assist the overall working of Indian Pharmaceutical team Other possible tasks appointed by Supervisors Note: We do not have own laboratories in India! Primary Skills (Essential) Minimum 4 years work experience in Analytical Development or Pharmaceutical product development or Quality Assurance activities in global Pharma industry Knowledge of EU and US requirements and ICH guidelines Practical development skills from the laboratory work and troubleshooting Task oriented with learning attitude and Teamwork skills Fluency in oral and written English Confirmed skills of Microsoft Office is essential Pharmaceutical education & practical analytical development skills also from the laboratory to production scale of different types of formulations (tablets, capsules, liquids, etc.) will have added advantage Candidate interested/experienced in above documentation work will be preferred. This Job offers An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals 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 Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel Education Masters degree in chemistry from a reputed College / University 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 / . How to apply and additional information Required documents: CV/Resume Application deadline: 05.07.2025

Job Description FinOrion Pharma India Pvt. Ltd. ( http://www.orionpharma.in ) is a wholly owned subsidiary of Orion Pharma, Finland. Our office in India strengthens Orion Pharma’s global partnerships and provides valuable support to our head office across several key business areas.The India office plays an important role in Orion Pharma’s global operations and R&D activities. Our teams contribute to areas such as supply chain, quality assurance, product life cycle management, regulatory support, and medical communications — all with the shared goal of advancing Orion Pharma’s mission to build well-being. Through strong collaboration and deep expertise, FinOrion Pharma India continues to grow as an integral part of OrionPharma’s global success story. Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. Orion Pharma provides meaningful work for more than 3 800 Orionees across the world and is known as a responsible and reliable employer where we value each other, strive for the best and build for tomorrow. Roles And Responsibilities Partner with hiring managers to understand staffing needs and define job requirements. Manage end-to-end recruitment processes including job postings, resume screening, interviewing, offer negotiation, and onboarding. Build and maintain a strong talent pipeline through proactive sourcing via LinkedIn, job portals, networking events, and referrals. Utilize our people management system MyOrion to track, manage, and report on candidate activity. Coordinate with external recruitment agencies when required. Ensure a positive candidate experience throughout the recruitment journey. Maintain and report recruitment metrics and provide insights for process improvement. Support talent development activities. Stay updated with market trends and best practices in talent acquisition, especially in the pharma sector Our Expectations 4–5 years of relevant experience in talent acquisition or recruitment. Prior experience in pharmaceutical or healthcare recruitment is highly desirable. Excellent sourcing techniques and knowledge of job boards, LinkedIn Recruiter, and other sourcing tools. Strong communication and interpersonal skills. Ability to multitask, manage priorities, and work in a fast-paced environment. Familiarity with HR systems and applicant tracking systems (ATS) We Offer An opportunity to work on challenges that matter and see the difference your work makes every day. The chance to grow in a company that invests in your continuous learning and professional development. Exposure to agile and future-focused ways of working in a company that values innovation, ethics, and sustainability. A hybrid and flexible way of working that supports a healthy work–life balance Education Education: Bachelor’s degree in Human Resources, Business Administration, or a related field. 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. Show more Show less

Job Description About your role We have vacancy for Product information expert role in Regulatory Affairs team. We are looking for Executive/Senior executive. The candidate has the possibility to utilize his/her own strengths with the support of the professionals. Your Key Responsibilities Management and coordination of good quality PI documents such as company core data sheets (CCDS), Summary of Product Characteristics (SmPCs), package leaflets (PLs) and labelling in close co-operation with Regulatory Affairs and Pharmacovigilance, including Writing PI documents with support from Medical Affairs, Commercial Operations and Global Operations Document management and change control of PI documents Performing quality control of PI documents for accuracy and consistency Global coordination and guidance of internal PI related processes Assuring high quality processes, internal guidelines, standard operating procedures & internal templates What We Offer An excellent opportunity to work as a PI-specialist in different therapeutic areas Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group An opportunity to collaborate directly with your colleagues mainly in Finland & India, but also globally 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 4 - 7 years of experience as Product Information Specialist in Pharmaceutical industry Advanced writing skills (e.g. SmPC, PL, other regulatory documents) Ability to understand complex medical terminologies and convert them into simple language Advanced computer and word processing (MS Word, Adobe Acrobat) skills Good communication and interpersonal skills Ability to prioritise, manage multiple projects & meet deadlines while delivering high quality documents Ability to work within teams (often remotely) as well as independently Positive attitude and willingness to learn and adapt, but also to teach and support co-workers and colleagues around the world Ability to keep sight of the bigger picture, while at the same time paying attention to details. Ability to work in a highly regulated industry Qualification Bachelor’s/Master’s degree in life sciences, B.Pharm/M.Pharm or health-related field from a reputed college How To Apply And Additional Information Email your CV on recruitmentindia@orion.fi & please share below details, Required documents, CV/Resume Current CTC, Expected CTC & Notice Period. Application deadline - 15.06.2025 Employer Description 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. About Orion 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.

Job Description Description of position You will work as a technical expert in Laboratory IT service as well as provide application support related to the laboratory systems. You will work in close cooperation with business administrators, colleagues from the Orion Information Management team and infra service providers for technical implementations, troubleshooting and technical changes. Key Responsibilities Managing system configuration, enhancement and life cycle Providing 2nd level application support and utilizing 3rd level support Problem solving of various technical issues related to different phases of systems life cycle Appropriate technical and user testing and documentation to comply with the industry regulations Acting as a subject matter expert in concepting, implementation and upgrade projects Understanding Laboratory systems and processes to match the demand with an optimal solution and/or configuration Description Of Unit The Business Solutions OT team is a team of Service Managers, Solution Experts, System Specialists and Solution Architect specialized to support and develop the IT systems in laboratories and production. We offer Orion's Information Management supports Orion’s success with data, digital services and solutions. As a member of this community, you are able to contribute and effect on how Orion improves well-being of our customers. We have a good working atmosphere based on common values and mutual trust. Read more about Orion as an employer. Requirements Required skills and competences needed for this role: Experience on application support and lifecycle management in a corporate organization IT technical knowledge on e.g. database, servers, network, AD, SSO, DNS, firewalls, API keys Ability to understand business needs and translate those into small enhancements or solutions Capability to manage architectural concepts of own solutions Ownership, initiative and drive. You can take accountability of the issues that occur and are motivated by solving problems and seeing the results of your work in effective use Excellent collaboration and communication skills, positive “can do” attitude as well as taking responsibility Team and business first mindset, ability to work, collaborate and communicate effectively with various cross-functional stakeholders Fluent language skills in Finnish and English Considered As An Advantage Experience in Laboratory systems, like e.g. LIMS, CDS, ELN, LES Experience of managing applications in regulated life sciences / pharmaceutical industry Service Management Framework knowledge Experience in multivendor environment 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.

Roles and Responsibilities Responsible for planning stability studies, writing and/or review of stability protocols, reports and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents and troubleshooting etc. for externally supplied products. Write documents into Orion s IT systems for example analytical methods Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to PQRs. Requesting, follow-up and tracking of PQR related data. Review of Externally supplied PQRs, related coordination and follow up with vendor and and other stakeholders Theoretical evaluation of physico-chemical properties of the drug products and/or raw materials Co-operation with other departments/ partners Local in-licensing support To assist the overall working of Indian Pharmaceutical team Other possible tasks appointed by Supervisors Note: We do not have own laboratories in India! Primary Skills (essential) Minimum 4 years work experience in Analytical Development or Pharmaceutical product development or Quality Assurance activities in global Pharma industry Knowledge of EU and US requirements and ICH guidelines Practical development skills from the laboratory work and troubleshooting Task oriented with learning attitude and Teamwork skills Fluency in oral and written English Confirmed skills of Microsoft Office is essential Pharmaceutical education & practical analytical development skills also from the laboratory to production scale of different types of formulations (tablets, capsules, liquids, etc.) will have added advantage Candidate interested/experienced in above documentation work will be preferred. This job offers: An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals 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 Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel Education Masters degree in chemistry from a reputed College / University. 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 / . How to apply and additional information Please fill Candidate Information Form on https: / / forms.gle / o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi Required documents: CV/Resume Application deadline: 18.07.2025

Job Description Roles and Responsibilities Responsible for planning stability studies, writing and/or review of stability protocols, reports and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents and troubleshooting etc. for externally supplied products. Write documents into Orion’s IT systems for example analytical methods Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to PQRs. Requesting, follow-up and tracking of PQR related data. Review of Externally supplied PQRs, related coordination and follow up with vendor and and other stakeholders Theoretical evaluation of physico-chemical properties of the drug products and/or raw materials Co-operation with other departments/ partners Local in-licensing support To assist the overall working of Indian Pharmaceutical team Other possible tasks appointed by Supervisors Note: We do not have own laboratories in India! Primary Skills (essential) Minimum 4 years' work experience in Analytical Development or Pharmaceutical product development or Quality Assurance activities in global Pharma industry Knowledge of EU and US requirements and ICH guidelines Practical development skills from the laboratory work and troubleshooting Task oriented with learning attitude and Teamwork skills Fluency in oral and written English Confirmed skills of Microsoft Office is essential Pharmaceutical education & practical analytical development skills also from the laboratory to production scale of different types of formulations (tablets, capsules, liquids, etc.) will have added advantage Candidate interested/experienced in above documentation work will be preferred. This Job Offers An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals 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 Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel Education Master's degree in chemistry from a reputed College / University. 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/ . How To Apply And Additional Information Please fill Candidate Information Form on https://forms.gle/o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi Required documents: CV/Resume Application deadline: 18.07.2025 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.

Job Description Roles and Responsibilities To perform product lifecycle management tasks for externally supplied products and own production products like evaluation of change controls, deviations, temperature excursions, stability data, process validation documents from Product quality point of view. Handling of problem-solving cases for products (includes both analytical and formulation related changes which have impact on product quality). Overall product quality evaluation and provide input during supplier's meetings. Follow up with suppliers and/or other stakeholders for documents related to changes for externally supplied products. E.g., possible impurities in API and finished products risk assessment in line with updated guidelines. Requesting, follow-up and tracking of Product Quality Review (PQRs) related data. Preparation and evaluation of Product Quality Review (PQRs) for externally supplied products, related coordination and follow-up with suppliers and other stakeholders. Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to Product Quality Review (PQRs). Responsible for planning stability studies, writing and/or review of stability protocols, reports and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at CROs/CQC. Writing and/or reviewing of process validation, technology transfer, study batch documentation for own products. Write/check/review pharmaceutical documents as per regulatory requirements. Candidate having knowledge of theoretical and/or possible Physico-chemical risks for products based on appropriate available data (E.g., evaluation of synthesis route of API, excipients, packaging materials details etc.) will be an added advantage. Write documents into Orion’s IT systems. Preparation and maintenance of lists/documents/records and archiving at appropriate place. Co-ordination with other departments / partners. Achievements of responsibilities within the agreed timelines. To assist the overall working of Indian Pharmaceutical team. Other possible tasks appointed by Supervisors. Note: We do not have own laboratories in India! Primary Skills (essential) Minimum 4 years' experience in Formulation R&D or API R&D activities in global Pharma industry Knowledge of organic chemistry/ Pharmaceutical medicinal chemistry/ synthetic chemistry will be an added advantage Ability to analyze the impact of change on Nitrosamine and/or other relevant physico-chemical risks assessment, if possible. Confirmed knowledge of EU requirements and ICH guidelines Candidate having interest and/or experience in pharmaceuticals documentation or any relevant pharmaceutical formulation / manufacturing related documentation will be preferred. Practical development skills from the laboratory to the production scale concerning different types of formulations (tablets, capsules, liquids, etc.) will be considered as an added advantage. Fluency in oral and written English Task oriented with learning attitude and Teamwork skills Confirmed skills of Microsoft Office are essential This job offers An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals 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 professionals Flexible, high spirit working environment where your skills are appreciated Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel Education Bachelors/master's degree in pharmacy from a reputed College/University or Master's degree in chemistry from a reputed College/University 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/ . How To Apply And Additional Information Please fill Candidate Information Form on https://forms.gle/o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi Required documents: CV/Resume Application deadline: 31.07.2025 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.

Roles and Responsibilities To perform product lifecycle management tasks for externally supplied products and own production products like evaluation of change controls, deviations, temperature excursions, stability data, process validation documents from Product quality point of view. Handling of problem-solving cases for products (includes both analytical and formulation related changes which have impact on product quality). Overall product quality evaluation and provide input during suppliers meetings. Follow up with suppliers and/or other stakeholders for documents related to changes for externally supplied products. E.g., possible impurities in API and finished products risk assessment in line with updated guidelines. Requesting, follow-up and tracking of Product Quality Review (PQRs) related data. Preparation and evaluation of Product Quality Review (PQRs) for externally supplied products, related coordination and follow-up with suppliers and other stakeholders. Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval. Preparation and review of other documents related to Product Quality Review (PQRs). Responsible for planning stability studies, writing and/or review of stability protocols, reports and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at CROs/CQC. Writing and/or reviewing of process validation, technology transfer, study batch documentation for own products. Write/check/review pharmaceutical documents as per regulatory requirements. Candidate having knowledge of theoretical and/or possible Physico-chemical risks for products based on appropriate available data (E.g., evaluation of synthesis route of API, excipients, packaging materials details etc.) will be an added advantage. Write documents into Orion s IT systems. Preparation and maintenance of lists/documents/records and archiving at appropriate place. Co-ordination with other departments / partners. Achievements of responsibilities within the agreed timelines. To assist the overall working of Indian Pharmaceutical team. Other possible tasks appointed by Supervisors. Note: We do not have own laboratories in India! Primary Skills (essential) Minimum 4 years experience in Formulation R&D or API R&D activities in global Pharma industry Knowledge of organic chemistry/ Pharmaceutical medicinal chemistry/ synthetic chemistry will be an added advantage Ability to analyze the impact of change on Nitrosamine and/or other relevant physico-chemical risks assessment, if possible. Confirmed knowledge of EU requirements and ICH guidelines Candidate having interest and/or experience in pharmaceuticals documentation or any relevant pharmaceutical formulation / manufacturing related documentation will be preferred. Practical development skills from the laboratory to the production scale concerning different types of formulations (tablets, capsules, liquids, etc.) will be considered as an added advantage. Fluency in oral and written English Task oriented with learning attitude and Teamwork skills Confirmed skills of Microsoft Office are essential This job offers An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals 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 professionals Flexible, high spirit working environment where your skills are appreciated Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel Education Bachelors/masters degree in pharmacy from a reputed College/University or Masters degree in chemistry from a reputed College/University 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 / . How to apply and additional information Please fill Candidate Information Form on https: / / forms.gle / o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi Required documents: CV/Resume Application deadline: 31.07.2025