Stillingstittel: Regulatory Affairs Lead Pharma, Global Omega-3

Stillingsbeskrivelse:
Pronova BioPharma - now part of BASF is a pioneer in the field of research, development, and manufacturing of omega-3 fatty acids. Pronova BioPharmas first commercialized pharmaceutical product is marketed in a number of countries throughout Europe, Asia and in the United States. On January 31, 2013 BASF aquired Pronova BioPharma and established an Omega-3 Verbund. With that BASF leverages its global market presence in dietary supplements, pharmaceuticals and clinical nutrition. The Verbund includes production facilities in Norway, and Scotland and the headquarters in Lilleaker (Oslo), Norway.Head of Regulatory Affairs - Omega-3 Pharma - Global headquarters - CMC Are you ready for an international career opportunity? Do you want to work with high quality products in a sustainable sector? Do you have leadership experience from Regulatory Affairs within pharmaceuticals? Are you motivated by developing your team? BASF has located its global focus on Omega-3 to Oslo, which provides a unique opportunity to take full responsibility for the regulatory affairs department dealing with Omega-3 classified as pharmaceuticals from the head office. You will report to the Vice President Commercial Affairs and work closely with your colleagues within Regulatory Affairs in the BASF´s global matrix. You will be responsible for pharmacovigilance and all regulatory work associated with the documentation of our Omega-3 pharmaceuticals (API, Drug Product) to support clinical trials and existing MAs. Your main tasks and accountabilities will be:

• Build top notch competence and capacity within the Pharmacovigilance and Regulatory Affairs area
• Lead and develop the department in daily operations
• Ensure that there are necessary instructions/procedures (SOPs)/ practices for the different areas of responsibilities.
• Plan and ensure that regulatory applications and registrations are submitted in accordance with the priorities agreed in the company - including follow-up questions from authorities / partners until regulatory approval.
• Regulatory guidance and expertise in defined areas for corporate needs.
• Contact with partners / drug authorities for CMC-related issues.
• Contribute to the fact that Omega-3 Verbund factories complies with the marketing authorizations.
• Develop and maintain CMC documentation as basis for clinical trials / marketing authorizations / licensing to partner and changes in this documentation
• Be the contact person for QA regarding the “change control process”
• Participate in the development of the regulatory strategy for new variations
• Regulatory activities and contributions to cross-functional life-cycle projects – from early stage development to post marketing
• Perform a regulatory review and impact assessment of change controls pertaining to planned changes at manufacturing sites
• Global contact with international colleagues (esp. the global Regulatory Affairs team) is a significant part of the role

We are looking for a candidate with a PhD or a Master’s degree within Life Sciences and 7-10 years of experience with Regulatory Affairs within pharmaceuticals. A minimum three years of leadership experience is required, and experience with CMC is an advantage. You are said to have a good business understanding, and we hope that you have a good insight in GxP and knowledge of general IT systems. As we work in a global team, all our employees must be fluent in English, and it will be an advantage to master one of the Scandinavian languages. As a person, you enjoy beeing a leader, are proactive, organised and solution oriented. You like to work on many activities simultaneously, you are independent, and enjoy taking responsibility. The position requires an eye for details, but also the ability to take an overall

Minstelønn: 0

Maksimal lønn: 0

Arbeidsgiver Navn: Pronova Biopharma Norge AS

Arbeidsgiver adresse: 0283 OSLO

Job kort beskrivelse: Pharmacists

Land: Norge

Region: Oslo

Kilde til jobbtilbud: NAV, Offentlige arbeidsformidlinger, Norge

Lønn valuta: NOK

Lønn periode: Pr. år