Karo Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 100 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and Mamp;A. Since 2019, under EQT ownership, we're rapidly heading towards a 1 billion European leadership position in consumer health.
Join us at Karo Healthcare on our exciting journey. We're currently looking for a Global Regulatory Affairs Manager, LCM (1 year maternity cover) for our office in Maidenhead.
Aim of the job
The primary purpose of this position is to be the global RA manager LCM (Labeling and compliance), responsible for a defined medicinal product portfolio. The global RA LCM Team is responsible for managing regulatory procedures, submissions, and projects related to safety variations, MAAs, PSURs, renewals, new product launches, OTC switches, and MAT projects.
The role involves ensuring adequate and timely planning, preparation, submission, and follow-up of regulatory procedures, while considering cross-functional impact and maintaining communication as needed.
This position also requires leading projects from a regulatory point of view, understanding the interdependencies between departments and their impact on the outcome. Collaboration with Commercial, Medical, and Operations Teams, as well as Local Partners and Publishing, is essential to ensure compliance and meet timelines.
For products within defined responsibility, including but not limited to:
- Manage the core and local regulatory dossiers, life cycle management and compilation of submissions for medicinal products
- Creation and/or review of regulatory documentation relevant for submission
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
- Provide regulatory input to cross functional teams/projects
- Co-ordinating subsidiaries, partners and consultants on applicable market(s)
- Regulatory project lead when relevant
- Product Information - creation, revision and translations to local languages
- Ensure updates of applicable national databases and product monograph websites
- SOP development and maintenance
- University degree in Life Science
- Good understanding of regulatory requirements and applicable legal frameworks
- Extensive record of variation management, including strategies
- Artwork maintenance and associated label requirements
- Experience of the National, DCP and MRP procedures
- Record of cross-functional duties and interactions (within Scientific Affairs, towards Operations and commercial functions as well as external stakeholders and partners of different sorts)
- Strong working relationship/experience of regulatory authorities
- Understanding of relevant regulatory databases, such as compendial databases
- Knowledge and understanding of CMC is meritorious but not a requirement
- Languages: English, Swedish
- Communicative (written and verbally), collaborative and structured
- Prestigeless, generous about sharing knowledge and ideas
- Solution-oriented and flexible ability to look at issues from different angles and challenge status quo, striving to offer solutions
- Good at calibrating standards of work and seeing the big picture, not getting stuck in details
- Ability to independently organise, sequence, prioritise and carry out given tasks including decision making, as necessary
- Open minded and appreciative towards an evolving and dynamic workplace where cross-functional collaboration and own initiatives are key
- Care for the wellbeing of our colleagues and end-users of our products
- Opportunity to create, grow, and encourage
- Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
- Flexible schedule and life work balance
- Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
- Very positive work environment in a young, international, and motivated team
- Start-up spirit while being a part of the large international organization with strong values
Karo Healthcare has a Diverse amp; Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.