Regulatory Affairs Manager
Share
Job Location:
Monthly Salary:
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
Do you want to play a key role in ensuring regulatory compliance and lifecycle management for innovative vaccines Valneva Sweden is looking for a proactive and detail-oriented Regulatory Affairs Manager to join our team in Solna.
About us
We are a specialty vaccine company that develops manufactures and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach applying our deepexpertiseacross multiple vaccine modalities focused on providing either first- best- or only-in-class vaccine solutions.
Valneva operates inAustria Sweden the UKFranceCanadaand the USAwitharound800employees. Valneva Sweden AB has a longhistoryin Sweden andtodayoperatesfrom Solna.
Learn more at
About the role
As Regulatory Affairs Manager you will manage regulatory maintenance for Valneva Swedens products across global markets including preparing changes and registration applications. You will review packaging materials forDukoralin collaboration with production QC supply chain marketing and sales and ensure medical and promotional informationcomplies withapproved texts and guidelines. You will also provide regulatory support for local change cases and other agreed activities such as distribution products.
Key responsibilities
- Prepare andsubmitregulatory applications to authorities
- Lead orparticipatein projects related to local change cases
- Communicate authority decisions internally
- Monitor and share updates on regulatory requirements
- Maintainhigh standardsof regulatory documentation
- Ensure consistency between approved documentation and manufacturing/QC specifications
- Manage registration and license applications for lifecycle andnew marketingauthorizations
- Oversee packaging material applications and ensure alignment with approved product information
- Evaluate regulatory impact of local changes
- Maintain compliance through SOPs archiving and housekeeping
- Support regulatory activities for distribution products in Nordic countries
Requirements
- Bachelors degree or higher in a relevant discipline (Regulatory Affairs Certification GMP training or Swedish/EU regulatory certificates are a plus)
- Minimum 3 years experience in a similar role
- Strong Microsoft Office skills
- Fluency in Swedish and English spoken and written
- Previousexperience in Life Sciences is an advantage
- Proactive detail-oriented and solution-focused
- Strong interpersonal skills and ability to build relationships
- High integrity confidentiality and ability to work under pressure
- Excellent prioritization and organizational skills
Benefits
Employment & benefits
This is a permanent position with a 6month probation an employee at Valneva you willbenefitfrom severalperksthat support both your health and your development:
- Competitive salary under the applicable Swedish collective agreement
- Access to occupational health services
- Wellness allowance
- Vaccinations and reimbursement for medical visits and prescription medicines
- ITP occupational pension
- Eligibility for bonus and stock option programs
How to apply / Questions
Selection and interviews are ongoingpleasesubmityour application as soon as possible.
Questions Contact HR:
Please note: We respectfully decline contact from recruitment and staffing agencies or suppliers.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused ... View more
