CMC Regulatory Affairs Manager to Intervacc

Job title:

CMC Regulatory Affairs Manager to Intervacc

Company

Intervacc AB

Job description

At Intervacc, we are pioneering the next generation of veterinary vaccines through our proprietary technology platform. Rooted in research from the Karolinska Institutet (KI) and the Swedish University of Agricultural Sciences (SLU), our mission is to reduce the impact of bacterial infections in animals through innovative, effective, and safe vaccines.Our first proprietary product – a vaccine against strangles, a serious streptococcal infection in horses- is now available in several European markets. This is just the beginning. We are expanding our reach into new territories and broadening our product portfolio.We have an exciting new opportunity for a CMC Regulatory Affairs Manager who will be responsible for the CMC regulatory strategy and execution for the company’s marketed products, in additions to supporting the development and commercialization of new vaccine products. The CMC Regulatory Affairs Manager will have a central role in providing guidance, support, and technical expertise for CMC activities and related regulatory initiatives. You will work with different markets to fulfil a key role within our dedicated, friendly and experienced team. If this sounds interesting to you – come join us!Intervacc AB is headquartered in Stockholm Sweden and is listed on the Swedish Nasdaq First North Growth Market. The position is full-time, and we welcome your application today!Key responsibilitiesAs a CMC Regulatory Affairs Manager, you will provide CMC regulatory strategy input and expertise for our marketed and investigational products to ensure the company’s products are developed and maintained in compliance with global regulatory requirements and guidance.Duties and responsibilities include:

• Prepare, review, and submit CMC regulatory documents throughout the product lifecycle

• Develop and implement CMC regulatory strategies to support clinical development, registration, and post-approval changes

• Act as the primary CMC regulatory contact with health authorities, internal teams, and external partners

• Oversee change control processes and ensure timely reporting of CMC variations and updates

• Tracking of all regulatory activities and housekeeping of the filed documentation

• Maintain compliance with global regulatory requirements and support regulatory inspections and audits

Skills and CompetenciesThe suitable candidate has the following qualifications:

• Formal academic degree level in a science-related subject e.g. pharmacy, biology or chemistry

• CMC Regulatory Affairs experience with submissions for biologics or biotechnology-derived products e.g. vaccines

• Knowledge of the drug development process for biologics (including upstream and downstream processes and analytical methods) and regulatory submissions

• Knowledge of current regulatory CMC requirements

• Understanding of regulations and guidance for the manufacturing of biotechnology products

• Excellent communication and documentation skills in English are required

The successful candidate for this position will be someone who:

• Is analytical, solution-oriented with a strong personal drive

• Is structured and organized but also adaptable to change

• Has a good eye for detail and a thorough approach to work

• Is a proactive, flexible, motivated and ambitious team player

If you are ready to bring your expertise in CMC Regulatory Affairs, we are ready to offer you an excellent career opportunity at an innovative company with an exciting journey ahead!About Intervacc:Intervacc is an innovative Swedish biotechnology company that develops and markets modern, effective, and safe vaccines against bacterial infections affecting animals. Over the past decade, advances in molecular biology techniques have significantly enhanced our ability to investigate the genomes of pathogenic bacteria. Building on our research foundations at the Karolinska Institutet (KI) and the Swedish University of Agricultural Sciences (SLU), we have developed a technology platform for a new generation of vaccines. Our first proprietary vaccine, a vaccine against the streptococcal infection strangles, which affects horses-is now available in several European markets. The Intervacc share (STO: IVACC) is listed on the NASDAQ First North Growth Market and our headquarter is in Stockholm, Sweden. You can find more information about Intervacc at www.intervacc.seFor more information about this position, please contact:Krishan Johansson Haque, PhDSr Recruitment Consultant, QRIOS Life Science & EngineeringT: +46 (0)72-070 16 53E:

Expected salary

Location

Stockholm

Job date

Fri, 06 Jun 2025 01:23:38 GMT

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