Regulatory Affairs Manager - EMEA - OTC - UK or Sweden Job

Job description

Regulatory Affairs Manager
- EMEA
- OTC
- UK or Sweden-1500047733WDescriptionTake the opportunity to become part of the success story behind one of the world’s fastest growing consumer companies. At Johnson & Johnson we have a truly unrivalled brand portfolio with power brands across multiple categories including Johnson’s®, Neutrogena®, Clean & Clear®, Listerine®, Calpol®, and Sudafed®. We have achieved consistent growth and our breakthrough plans for the future make this a great place to further your career.
Position Title: Regulatory Affairs Manager EMEA
- OTCLocation: Maidenhead, UK or Helsingborg, SwedenClosing Date: 17th July 2015Position Summary:We have an excellent opportunity for a Regulatory Affairs Manager – Emea, covering the OTC category and reporting into the Director of Regulatory Affairs. The role can be based in either the UK or Sweden.
You will be responsible for the following key areas:
- Manage and execute regulatory activities across EMEA withing OTC Brand Categories to meet commericial/regulatory requirements.
- Develop OTC regulatory strategies and formulate registration plans
- Manage EMEA regulatory functions as these relate to OTC, to provide a proactive, cost effective, efficient and competent regulatory affairs service dedicated to meeting the needs of its European and World-wide customers.
- Proactive and credible business partner to EMEA Franchise and in-market business colleagues.
- Provide regulatory strategies to guide Global New Product.
- Develop and contribute to Global Regulatory process development for OTC products.
Main roles and responsibilities:
- Determine and manage resources to execute regulatory activities in support of EMEA OTC Brand plans
- Align with EMEA OTC Franchise to identify and set project timings and ensure appropriate EMEA resource is available to execute appropriately.
- Support continuous improvement in regulatory knowledge.
- Use regulatory knowledge to execute regulatory activities in support of EMEA OTC Brand plans
- Partner with EMEA Medical Affairs Category/Global R&D to develop European R&D plans in support of Franchise and brand objectives.
- Lead multiple projects and represent the function as a prime internal Regulatory contact
- Dependent upon business priorities take regulatory leadership role on specified projects.
- Provide Local/Regional Regulatory feedback on all global initiatives to ensure all EMEA
- regulatory requirements for OTC products are understood at a Global level.
- Develop and input to EMEA Brand plans for OTC products by understanding and shaping the external environment
- Provide a regulatory intelligence support service to Regulatory personnel in line with project responsibilities.
- Proactively represent JJCG in external Industry Bodies, where appropriate.
- Undertake Change Management activities to ensure the continuous evolution of the EMEA Regulatory Affairs OTC function
- To ensure the maintenance of adequate records of regulatory activities and registrations
- To ensure the generation of a maintenance library for pharmaceuticals, cosmetics and medical devices
- Liaison with regulatory agency personnel (where required)
- Influence industry bodies to ensure Industry position is appropriately represented.
- To provide regular updates and reports.
- To specifically develop strong working relationships with affiliate regulatory contacts and the business.
QualificationsEducation and Qualifications:
- Life Science Degree or equivalent. High levels of intellectual capacity and curiosity.
- 5-7 years of progressive experience in European Regulatory Affairs, in particular good working knowledge of the European procedures (Mutual Recognition
- Decentralised procedure)
- Demonstrate excellent leadership and communication skills.
- Demonstrate strong organisational skills, including the ability to prioritise workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific and manufacturing.
- Strong sensitivity for multi-cultural/multi-National environments.
- Well organised, detail-oriented, effective in written and oral communication.
- Ability to undertake financial management.
What type of mark will you make? Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world.
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices Act.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-MaidenheadOrganization: J&J Consumer Services EMAE., Ltd (8675)Job Function: Regulatory Affairs