Regulatory Affairs Manager (f/m/d)

Bavarian Nordic; Martinsried; Ibrido; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Bavarian Nordic is seeking a Regulatory Affairs Manager to lead global regulatory activities from Martinsried, with hybrid work options. You will drive lifecycle management, post‑approval strategies, and submission quality while coordinating with international health authorities.

The role requires a Master’s degree in Life Sciences and at least 5 years of regulatory experience in pharma, with strong EU/US knowledge and English communication skills. Occasional travel is expected.

Competenze

• Master’s degree in Life Sciences or related field.
• Minimum of 5 years regulatory affairs experience.
• Experience with EU and US regulatory frameworks.

Mansioni

• Lead regulatory activities for assigned lifecycle management projects, including global product expansions.
• Develop and execute regulatory strategies for post‑approval activities, ensuring alignment with business objectives and global regulatory requirements.
• Prepare, coordinate and submit high‑quality regulatory documentation, including briefing packages, variations, supplements and MA submissions.
• Act as the Regulatory Affairs lead within cross‑functional project teams, providing strategic guidance during post‑authorization processes.
• Coordinate responses to health authority questions and regulatory review procedures, ensuring timely and compliant interactions worldwide.
• Monitor evolving regulatory requirements and communicate updates to stakeholders.

Formazione

Master’s degree in Life Sciences

Descrizione del lavoro

## Regulatory Affairs Manager (f/m/d)Apply: Hybrid (remote and on-site): Thorishaus: Full time: Posted Today: JR101547Join our Regulatory Affairs team and play a pivotal role in bringing innovative biologic products to patients worldwide. As Regulatory Affairs Manager located in Martinsried (Munich), Törishaus (Bern) or Kvistgaard, you will lead global regulatory activities across product registration and lifecycle management, working closely with cross-functional teams and health authorities.This is an exciting opportunity for an experienced regulatory professional to shape regulatory strategies, drive successful submissions, and contribute to the delivery of high-quality healthcare solutions. Occasional travel should be expected.**Your responsibilities*** Lead regulatory activities for assigned lifecycle management projects, including global product expansions* Develop and execute regulatory strategies for post-approval activities, ensuring alignment with business objectives and global regulatory requirements* Prepare, coordinate and submit high-quality regulatory documentation, including briefing packages, variations, supplements and marketing authorization submissions* Act as the Regulatory Affairs lead within cross-functional project teams, providing strategic guidance throughout post-authorization processes* Coordinate responses to health authority questions and regulatory review procedures, ensuring timely and compliant interactions with regulatory agencies worldwide* Monitor and interpret evolving regulatory requirements, guidelines and legislation, communicating relevant updates to stakeholders and supporting organizational compliance* Contribute to regulatory operational excellence through process improvements, and the development and maintenance of Regulatory Affairs SOPs and work instructions**About you*** Master’s degree in Life Sciences (e.g., Biology, Molecular Biology, Biochemistry, Pharmacy) or a related scientific discipline* Minimum of 5 years of Regulatory Affairs experience within pharmaceutical drug development, ideally in a global environment* Strong understanding of regulatory submission and approval processes, including experience with major regulatory frameworks such as EU and/or US* Ideally experience supporting the registration and lifecycle management of biologic products* Solid knowledge of pharmaceutical regulations and regulatory intelligence, with the ability to interpret evolving requirements and provide sound regulatory guidance* Excellent communication and stakeholder management skills, with the ability to collaborate effectively across cross-functional and international teams; fluent in written and spoken English* Highly detail-oriented with strong analytical skills, including the ability to evaluate scientific data and translate complex information into high-quality regulatory documentation; proficient in standard computer applications and digital systems**What We Offer*** A high‐ownership role with direct influence on operational performance, giving you clear responsibility and visible impact* Collaboration with international suppliers and cross‐functional teams, working in a dynamic and global environment* Professional development and growth opportunities within a forward‐thinking and innovation‐driven organization* A supportive team culture and a flexible working environment that values trust, autonomy and work–life balance**Are you ready to join us in our mission?**If this sounds like the next step in your career, simply click the \"APPLY\" button and you will be redirected to our application form. We are conducting interviews on an ongoing basis and encourage you to apply as soon as possible.Applications submitted via email will not be considered.We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.*Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.**Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.**For more information, visit**www.bavarian-nordic.com*