Regulatory Affairs & Quality Assurance Specialist
Om jobbet
Take your Regulatory Affairs expertise to the next level, step out your comfort zone and play a key role in shaping the future of the Nordic OTC and health segment.
Join Conaxess Trade Sweden as aQARA Specialist(full time permanent position) and step into a role that is as varied as it is rewarding. You will enjoy a high degree of freedom in how you work, with the chance to shape ideas and make things happen quickly.
Conaxess is a small, close-knit organization with short decision-making paths, which means that no heavy global bureaucracy slow you down. Here, innovation is encouraged, and your ideas can quickly turn into reality.
Most complaint registrations will be managed with the help of students, so your focus will be on the more exciting and challenging QA tasks - the kind that keep you learning, growing, and engaged every day.
Type of employment: Full-time permanent position at Conaxess Trade Sweden
Location:Sundbyberg, Stockholm, flexible to homework
Department:Regulatory Affairs Operations
Reports to:Senior Regulatory Affairs Manager
About your future working place
Conaxess Trade is one of the leading Sales, Marketing and Distribution companies in the Nordics. Our vision is to make brands more successful.
We are proud to announce our strategic collaboration with Cooper Consumer Health International (CCHI), establishing a solid presence in the Nordics for one of Europe's largest self-care portfolios, as the Nordic representative of a wide range of self-care products including many OTC pharmaceuticals.
Conaxess Trade is a small company working with the biggest brands. Among our most recognized products on the Nordic market can Treo, Zyx, VårtFri be mentioned. Being a small organization means a wide range of working tasks and the ability to influence your own working day.
Position Overview
The RA/QA Specialist at Conaxess Trade is a split role working with both supporting regulatory affairs processes across the Nordics as well as supporting the RP, Responsible Person, in its duties.
This role involves assisting in the preparation and maintenance of regulatory documentation as well as supporting the marketing team with information for launches and marketing activities. The Regulatory Affairs function at Conaxess Trade is an integrated and crucial part of the business.
This role also supports our RPs with its QA responsibilities and works closely with the supply team. Be the go-to person for quality-related questions on a day-to-day basis and help out to build strong but pragmatic processes for cross-functional work.
Typical work tasks
Regulatory Documentation and Submission:
- Assist in the preparation and compilation of regulatory documents required for variations, product information and artwork updates across the Nordics.
- Update and Maintenance of National databases and Catalogue texts
- Communication with regulatory agencies to track submission status and respond to requests for additional information.
Quality Assurance work:
- Conduct investigations on deviations
- Report on out-of-stock situations across Nordics
- Support the supply team for outstanding documents, temperature deviations
- Follow up on complaints sample requests by CMO
- Maintain QMS system, SOP training and writing.
Cross-Functional Support:
- Collaborate with Sales & Marketing with review of promotional material and development of supportive documents at customers listing
- Responding to various requests from MAH Cooper (CCHI) or Legal Manufacturers
- Assist in regulatory and quality processes
Documentation Management:
- Maintain well-organized records of regulatory documentation, including submission histories, regulatory correspondences, and approval documents.
- Ensure that all regulatory files are up-to-date and easily accessible within the company's document management system.
- Maintain well-organized records of quality related documents including eligible SOP writing.
Qualifications
Experiences:
- 2-3 years of experience in a regulatory affairs or quality assurance role, preferably within the pharmaceutical industry.
- Familiarity with regulatory submission processes and direct experience handling regulatory documentation and correspondence.
- Familiarity with quality work and SOP quality management system.
- Experience from reviewing promotional material and knowledge in industry ethical rules is meriting
- Experiences from OTC and FMCG segment are meriting
- Fluent in Swedish or other Nordic language and high proficiency in English
Skills:
- Attention to details and the ability to manage multiple tasks efficiently.
- Excellent organizational and communication skills.
- Proficiency in MS Office.
- Ability to work effectively under deadlines and within a cross-functional team environment.
- A can-do attitude and a business-oriented mindset
Education:
- A bachelor's degree in a scientific or related field is required.
- Additional qualifications or certifications in regulatory affairs or quality assurance are a plus.
Performance Indicators:
- Accuracy and timeliness of regulatory submissions and documentation.
- Effectiveness in supporting regulatory compliance activities.
- Contribution to maintaining and updating regulatory databases and documentation.
- On time assessment of deviation investigation and out-of-stock reporting.
- Positive feedback from cross-functional teams on regulatory support provided.
Note: This role offers variety and the flexibility to evolve with our business. While the description gives you a good overview, your responsibilities may grow and change as Conaxess Trade and the market continue to develop.
JoinConaxess Tradeand be part of a company where Regulatory Affairs is more than just a standalone function - it is a true business driver. Here, innovation, efficiency, and collaboration are at the heart of everything we do.
The next step
If you believe you have the experience and qualities we are looking for, please either apply to the position here with a complete application (motivation letter, CV) or contact Kristina Edholm for a confidential discussion (kristina.edholm@pharmarelations.se). Please do not submit any documents via email. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
Join Conaxess Trade Sweden as aQARA Specialist(full time permanent position) and step into a role that is as varied as it is rewarding. You will enjoy a high degree of freedom in how you work, with the chance to shape ideas and make things happen quickly.
Conaxess is a small, close-knit organization with short decision-making paths, which means that no heavy global bureaucracy slow you down. Here, innovation is encouraged, and your ideas can quickly turn into reality.
Most complaint registrations will be managed with the help of students, so your focus will be on the more exciting and challenging QA tasks - the kind that keep you learning, growing, and engaged every day.
Type of employment: Full-time permanent position at Conaxess Trade Sweden
Location:Sundbyberg, Stockholm, flexible to homework
Department:Regulatory Affairs Operations
Reports to:Senior Regulatory Affairs Manager
About your future working place
Conaxess Trade is one of the leading Sales, Marketing and Distribution companies in the Nordics. Our vision is to make brands more successful.
We are proud to announce our strategic collaboration with Cooper Consumer Health International (CCHI), establishing a solid presence in the Nordics for one of Europe's largest self-care portfolios, as the Nordic representative of a wide range of self-care products including many OTC pharmaceuticals.
Conaxess Trade is a small company working with the biggest brands. Among our most recognized products on the Nordic market can Treo, Zyx, VårtFri be mentioned. Being a small organization means a wide range of working tasks and the ability to influence your own working day.
Position Overview
The RA/QA Specialist at Conaxess Trade is a split role working with both supporting regulatory affairs processes across the Nordics as well as supporting the RP, Responsible Person, in its duties.
This role involves assisting in the preparation and maintenance of regulatory documentation as well as supporting the marketing team with information for launches and marketing activities. The Regulatory Affairs function at Conaxess Trade is an integrated and crucial part of the business.
This role also supports our RPs with its QA responsibilities and works closely with the supply team. Be the go-to person for quality-related questions on a day-to-day basis and help out to build strong but pragmatic processes for cross-functional work.
Typical work tasks
Regulatory Documentation and Submission:
- Assist in the preparation and compilation of regulatory documents required for variations, product information and artwork updates across the Nordics.
- Update and Maintenance of National databases and Catalogue texts
- Communication with regulatory agencies to track submission status and respond to requests for additional information.
Quality Assurance work:
- Conduct investigations on deviations
- Report on out-of-stock situations across Nordics
- Support the supply team for outstanding documents, temperature deviations
- Follow up on complaints sample requests by CMO
- Maintain QMS system, SOP training and writing.
Cross-Functional Support:
- Collaborate with Sales & Marketing with review of promotional material and development of supportive documents at customers listing
- Responding to various requests from MAH Cooper (CCHI) or Legal Manufacturers
- Assist in regulatory and quality processes
Documentation Management:
- Maintain well-organized records of regulatory documentation, including submission histories, regulatory correspondences, and approval documents.
- Ensure that all regulatory files are up-to-date and easily accessible within the company's document management system.
- Maintain well-organized records of quality related documents including eligible SOP writing.
Qualifications
Experiences:
- 2-3 years of experience in a regulatory affairs or quality assurance role, preferably within the pharmaceutical industry.
- Familiarity with regulatory submission processes and direct experience handling regulatory documentation and correspondence.
- Familiarity with quality work and SOP quality management system.
- Experience from reviewing promotional material and knowledge in industry ethical rules is meriting
- Experiences from OTC and FMCG segment are meriting
- Fluent in Swedish or other Nordic language and high proficiency in English
Skills:
- Attention to details and the ability to manage multiple tasks efficiently.
- Excellent organizational and communication skills.
- Proficiency in MS Office.
- Ability to work effectively under deadlines and within a cross-functional team environment.
- A can-do attitude and a business-oriented mindset
Education:
- A bachelor's degree in a scientific or related field is required.
- Additional qualifications or certifications in regulatory affairs or quality assurance are a plus.
Performance Indicators:
- Accuracy and timeliness of regulatory submissions and documentation.
- Effectiveness in supporting regulatory compliance activities.
- Contribution to maintaining and updating regulatory databases and documentation.
- On time assessment of deviation investigation and out-of-stock reporting.
- Positive feedback from cross-functional teams on regulatory support provided.
Note: This role offers variety and the flexibility to evolve with our business. While the description gives you a good overview, your responsibilities may grow and change as Conaxess Trade and the market continue to develop.
JoinConaxess Tradeand be part of a company where Regulatory Affairs is more than just a standalone function - it is a true business driver. Here, innovation, efficiency, and collaboration are at the heart of everything we do.
The next step
If you believe you have the experience and qualities we are looking for, please either apply to the position here with a complete application (motivation letter, CV) or contact Kristina Edholm for a confidential discussion (kristina.edholm@pharmarelations.se). Please do not submit any documents via email. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
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