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Regulatory & Quality Head, Nordics
On behalf of our customer Angelini Pharma - a leading company within healthcare, with particular strength and expertise in the fields of Mental Health and Epilepsy - we are looking for a Regulatory & Quality Head, Nordics to be part of the establishment in the Nordic markets. The position will be situated in the Nordic headquarters in Stockholm.
Angelini Pharma is the pharmaceutical division of Angelini Industries. The Group started almost 100 years ago as a small pharmaceutical laboratory, and over the years has grown into a leading international group within healthcare. Angelini Pharma is an integrated pharmaceutical company, with extensive R&D operations that has developed important molecules such as trazodone and benzydamine. The company is a leader in healthcare, with particular strength and expertise in the fields of Mental Health, Epilepsy and Rare Diseases. The company is also a leading player in the Consumer Health segment, with highly successful OTC brands worldwide.
Current research focuses on Nervous System Diseases and Disorders, Pain and Inflammation and Rare Diseases, with a particular commitment to the research of new treatments for the pediatric population. The research embraces public-private partnerships with recognized academic institutions and centers of global importance. The Scientific Network and Partnerships both have an important role in creating innovation.
Angelini Pharma Nordics is a newly established company. They are currently launching Ontozry (Cenobamate) in all Nordic countries and simultaneously building the foundation for future ventures. Ontozry is a potential novel anti-seizure medication for the treatment of focal-onset seizures for adult epilepsy patients. Currently they operate through a legal entity in Sweden and a branch in Denmark.
Local Quality System (QA-GDP/GMP matters)
- Performing all QA related tasks for Angelini Pharma Nordics. Assuming the role of Responsible Person (RP) for distribution activities performed under the local operational WDA license, ensuring compliance to local requirements.
- Representing the local company to Nordic authorities in all quality related matters.
- Set-up and maintain local SOPs and Training Systems management.
- Performing audits to local suppliers (logistics, warehouses) following the Angelini Pharma GDP QMS.
- Controlling and evaluating all locally outsourced, quality relevant activities, including quality agreements, in accordance with HQ established methodologies.
- Ensuring qualification of primary distribution customers following the Angelini Pharma GDP QMS.
- Establishing and maintaining the Local Quality Management System, in compliance with Angelini global QMS and in line with EU and national rules for Angelini Pharma Nordics, in cooperation with relevant departments in HQ.
- Handling of non-conforming products, complaints and process non-conformities.
- Informing the HQ QA & GDP International department about
- complaints, quality problems or other critical issues with impact on the product or service quality.
- relevant quality changes in the local organization and legislation, in relevant service provider’s organization and any inspection by the local health authorities.
- Reporting to the HQ QA & GDP International department the agreed KPIs.
- Assessing and managing products returned from the market.
- Ensuring activities related to Nordics regional medicines verification organizations, regarding the serialization of distributed medicinal product.
- Evaluating risk-based monitoring results, trends and remediation and applicable internal audit outcomes (CAPAs).
- Maintaining the oversight of the quality system and GDP related external parties/consultants in cooperation with RPI.
Support local and corporate business through:
- Regulatory input to the Country Manager, the Country Organization and the Global RA Global team. Ensure interaction and alignment with the Global RA team to support relevant priorities and objectives.
- Regulatory maintenance activities for the entire Angelini portfolio in the Country.
- Accountable for local Regulatory activities ensuring compliance with Angelini global/local procedures and with national and international law/regulations for the products (pharma and non-pharma) registered and distributed in the Country.
- Secure regulatory submissions and approvals in line with business expectation and Global indications/timelines
- Build and maintain relationship with National Regulatory Authorities involved in regulatory affairs assessments to get the relevant regulatory approvals
- Build and maintain strategic interactions with the Local Health Authorities to obtain the relevant approvals for regulatory applications (i.e., new MAAs, MA variations, MA renewals, certifications etc.).
- Build and maintain relationship with Trade Associations for regulatory activities.
- Provide regulatory strategic input to support commercial success of the Country Organization by increasing and maintaining products portfolio.
- Ensure maintenance and updates of Global RA systems for KPIs monitoring.
- Maintain the local regulatory documentation in the up-to-date shape and in line with the available Global Regulatory Affairs guideline.
- Manage the Regulatory Information Management System (RIMS) and Master Data Management (MDM) and Data Management System (DMS) of the company introducing all the relevant info and documents to allow a precise and correct tracking of data for the products registered in the Country.
Reporting to Country Manager, Nordics.
COMPETENCE REQUIREMENT AND ABILITIES
- Experience/expertise with MPA with regards to GDP Inspection preparation, hosting, follow-up
- Experience/expertise with MPA GMP/GDP Inspectorate
- Experience in Pharmaceutical sector 3+Y in Quality department of a pharmaceutical enterprise/ Country affiliate of a Global Pharma organization managing importation/distribution of medicinal products in the Nordics and Denmark
- Experience in Quality department of a Manufacturing entity is a plus
- Superior leadership skills, including ability to effectively negotiate with the Regulatory Authorities.
- Excellent interpersonal, communication and presentation skills.
- Good understanding of drug development and approval processes to get new MAs and LCM activities
- Innovative and critical thinking with performance-oriented drive.
- Proficiency in English is a must; Beyond Swedish native language, ability to manage other Nordics languages in written is a plus
- Strong attitude to innovation, including automation of QMS processes driven by information systems
- Ability to provide professionally presented, accurate reports and documentation
Morgan Eilenberg, +46 73 359 05 50 email@example.com , or
Adina Lekberg Salamon, +46 73 974 43 34, firstname.lastname@example.org
We meet candidates on an ongoing basis, so if you are interested in the position we look forward to receiving your application as soon as possible.