Regulatory Affairs Senior Manager in Oslo

Regulatory Affairs Senior Manager

Become part of a global leader in vaccines and pharmaceuticals development and innovation for aquaculture!

Why join PHARMAQ part of Zoetis?

PHARMAQ is the global leader in vaccines and pharmaceuticals development and innovation for the aquaculture industry and part of Zoetis, the world's leading animal health company. The company develops safe and effective medicines through targeted research and a highly skilled and dedicated staff. PHARMAQ has around 375 employees, with R&D and manufacturing facilities based in Norway and commercial operations located in Norway, Europe, North and South America and in Asia.

Our innovative drive is focused on the need to produce sustainable, safe and healthy seafood. As fish continues to be the most consumed and future crucial source of animal protein worldwide, we believe that fish health management tools, such as fish vaccines and pharmaceuticals, are key to developing a sustainable growth in global aquaculture.

In PHARMAQ part of Zoetis, we foster a highly collaborative culture and work across the business units to obtain results that matter. It is our colleagues that make the difference, and we strive to value the professional and personal development of every colleague.

Who are we looking for?

When hiring new employees, we look for the individuals who are inspired by PHARMAQ part of Zoetis dynamic and innovative spirit to create the next generation of solutions and services to support the evolving aquaculture industry. Our core beliefs are: Our Colleagues Make The Difference, Always Do The Right Thing, Customer Obsessed, Run It Like You Own It and We Are One Zoetis. We are now seeking a new Senior Manager in our Regulatory Affairs team.

Regulatory Affairs Senior Manager

As the global leader in fish health, the Regulatory Affairs team within PHARMAQ is responsible for the licensing and maintenance of the global portfolio of medicinal products for fish. Regulatory Affairs provides expertise on the regulatory framework which set the scene for development and approvability of medicinal products by regulators.

We are now seeking an experienced and highly motivated Regulatory Affairs Senior Manager to take a key role in development and registration of medicinal products. The candidate will be expected to lead or support activities and be able to present alternative options for regulatory strategies or solutions in cross functional project teams.

Regulatory Affairs offers a central position for the overall view of the documentation behind a product. In your role you will be actively engaged across the organisation, including experts in research and development, quality assurance, manufacturing, supply and the markets. You will be involved in preparation, review and summarising the documentation for the right purpose. Your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team.

Key responsibilities

• Actively engage in projects for planning of relevant documentation and regulatory strategy for new and existing vaccines and pharmaceuticals
• Lead processes for scientific guidance from regulatory authorities
• Contribute actively with R&D, manufacturing functions and other stakeholders to ensure that regulatory requirements and company procedures are applied
• The subject area is related to biological and/or pharmaceutical product, process & method development, and safety & efficacy documentation
• Review and quality control of protocols, reports and other texts to ensure consistent and high-quality documentation
• Summarise regulatory documentation for marketing authorisation applications and related submissions
• Actively being in the forefront of regulatory requirements and provide guidance and training across the organisation
• Plan and deliver results according to timelines

Qualifications and profile.

• Master in a relevant life science discipline, e.g. immunology, molecular biology, veterinary medicine, microbiology, pharmacy
• 5-10 years working experience from regulatory affairs or adjacent areas from the pharmaceutical, biotech or animal health industry or regulators
• Expertise from one or more fields related to virology, molecular biology, immunology, vaccinology, pharmaceutical development, process technology or clinical development
• Ability to manage multiple competing priorities and meet timelines
• You have a structured mindset with focus on quality
• Proven networking skills and ability to share knowledge and experience amongst colleagues
• Adaptability, accountability and a collaborative mindset is essential
• Fluency in English and Norwegian, both written and spoken, and interest for the writing process

The position is located in Oslo (Skøyen) at our modern and well-equipped offices. We offer a competitive compensation and benefits, flexible schedule and the opportunity to develop.

For further information about the position please contact:

Elin Bryhni

Senior Manager Regulatory Affairs

+47 95172940

Application:

We are looking forward to receiving your application, which you can send with your CV via email to hr@pharmaq.no by 10 October 2021. Applications will be considered on an ongoing basis. Copy of diplomas and testimonials are requested to be included in the interview. We are a pharmaceutical company and we will require police testimonial upon appointment.

PHARMAQ is the world's leading vaccine and innovation company focused on the aquaculture industry and part of Zoetis, the world's leading animal health company. The company develops safe and effective medicines for the aquaculture industry with a good environmental profile through targeted research and dedicated staff. Production, administration, research and development is located in Norway and the group's products are marketed in Europe, North and South America and in Asia. PHARMAQ has around 375 employees. For more information, see the company's website: www.pharmaq.com

By submitting an application and CV, you agree that the information you provide will be stored in our database to be able to assess you in our recruitment processes. The information will not be stored longer than necessary and maximum for 6 months. Should you have any questions about the safety of our recruitment processes, please contact us at e-mail hr@pharmaq.no. The applicant is entitled to withdraw the application at any time.