Manager Regulatory Affairs, Nordics, and Geo-expansion
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction – a chronic relapsing disease.
Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction – including opiate overdose, alcohol use disorders and cocaine intoxication – as well as related mental health disorders such as schizophrenia.
This position is responsible for providing guidance for, and management of regulatory activities related to Indivior with health authorities and local government regulations in the Nordic countries (Denmark, Finland, Norway, Sweden and Iceland). The role will also be responsible projects, including “geo-expansion” countries.
Amongst other duties you will
Nordic Regulatory Responsibilities (up to 50% of time)
- Support regional management and commercial team and assist Senior Regulatory Manager, Region North-West Europe, to manage local regulatory professionals to obtain and maintain all necessary pharmaceutical Marketing Authorizations (MA), price agreements and appropriate licenses/authorizations.
- Ensure approvals for Indivior’s narcotic drug business in compliance with individual health authority and local government regulations.
- Liaise directly with local health authorities to develop and lead regional regulatory strategies for product categories in line with global strategic plans.
- Ensure the registration and regulatory compliance of locally marketed products to bring competitive advantage to our brands. Amend registration dossiers as necessary for country-specific regulatory requirements and submit registration applications and negotiate with governmental authorities to obtain rapid approvals with favorable labelling and claims.
- Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware and informed early enough of significant regulatory expected changes and potential issues.
- Interface with local government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, clinical, marketing, advertising, labelling and production of our products.
- Work with regional and country commercial teams & provide support to local drug listings and promotional material copy clearance activities.
- Represent company interests with local government agencies, industry associations and/or other organizations for the purpose of negotiating legislation, regulations and/or guidelines that do not impose excessive or unfair burdens on our industry or products.
- Support development and maintenance of a database of local regulatory requirements accessible to the global team. Provide regulatory and product compliance expertise in advertising and label claims for existing and new products, as applicable.
- Provide technical support to respond to consumer and legal inquiries on regulatory issues for our products marketed locally. Report measures of product registration and regulatory compliance performance. Assist with local statutory reporting requirements. Provide regulatory documentation required by other functions.
- Provide regulatory supports to activities related to SOPs & training programs and regulatory compliance in the areas of regulatory affairs and pharmacovigilance. Provide local regulatory assistances to support commercial activities such as product release, QA/QC functions, supply chain issues, promotional material copy clearance. Maintain a dialog with Quality Assurance and Manufacture personnel at the Indivior site in Hull, England to share information and ensure best practices.
- Support and lead internal and external Audit initiatives for the region
- Support all activities to update Mock-ups and Commercial Artwork according to the valid SOPs and Work instructions in force
Projects Responsibility (up to 50% of time)
The role will involve leading and/or supporting projects including:
- Support Regulatory activities for Ireland, Malta, MENA LatAm
- Implementation of labeling variations
- Supervising translation with external translator
- Cross European workshare procedures
Travel may be required to support project work.
- Degree in Pharmacy/Chemistry/Biology/ Pharmacology or other science-related field.
- A minimum of 3–5 years’ experience in pharmaceutical regulatory affairs is required.
- Working knowledge of key health authorities in Nordics countries and ideally with other EU
- Experience of leading and managing regional projects.
- Strong project management skills (including vendor management)
- Experience in narcotic pharmaceutical business is a plus.
In this recruitment Indivior is cooperating with Compass Human Resources Group. If you want more information please contact Anders Larsson at email@example.com +46 73 203 4691 Morgan Eilenberg at firstname.lastname@example.org +46 733 590550