Regulatory Affairs Manager New Initiatives & Innovation

Regulatory Affairs Manager New Initiatives & Innovation

Wörwag Pharma

Böblingen, Germany

These tasks await you

• Provide best in class regulatory support & input throughout the whole Innovation process with product ideas ranging from food supplements (based on vitamins, minerals, pro-/prebiotics and other metabolites) over medicinal products (RX/OTC) to cosmetics & medical devices (e.g. digital health apps, drug device combinations);
• Regulatory evaluation and risk assessment of the new product ideas focusing on early identification of key regulatory challenges and regulatory risk/benefit evaluations associated with proposed strategies;
• Coordinate & integrate required Regulatory input to the Innovation group from Global level, the Country Regulatory Affairs of the key markets in scope as well as from external regulatory consultancies;
• Brief & obtain external regulatory assessments for product categories, business models & new geographies where knowledge does not exist inhouse;
• Keep abreast with changes to the regulatory landscape and requirements and communicate relevant changes to internal stakeholders; refine regulatory strategies as new data become available and reassess as necessary;
• Generate & maintain a “Regulatory Innovation work toolkit” preserving general learnings from working with innovation ideas;
• Face & facilitator of innovation culture & mindset for the Regulatory function; conducting training of employees on regulatory or innovation work related topics as required.

Your profile

• Completed degree in food chemistry, food technology, food & nutrition science, pharmacy or other suitable health-related science;
• At least 3-4 years of professional experience in Regulatory Affairs in Consumer Health with a focus on food supplements, medicinal products and ideally also cosmetics & medical devices;
• Good knowledge of the legal & regulatory requirements for food supplements also covering products where the characterizing substances are pro-/prebiotics, herbals or other non-vitamin/mineral metabolites – at least in EU and ideally also in other regions;
• At least basic knowledge of regulatory requirements for medicinal products, cosmetics and medical devices;
• Intrinsic preference for innovation work which requires an innovation mindset, agility, resilience, ability to deal with uncertainty, fast decision making and failure;
• Accurate, analytical, independent, integrative and responsible working practices, value-oriented & entrepreneurial thinking and acting;
• Demonstrated excellent organization and project management skills; ability to work in diverse teams in matrix setups and to complete tasks in a detail-oriented manner with high standard despite tight timelines;
• Excellent English communication skills (both oral and written; German and further languages an advantage); able to communicate effectively to convey complex technical information to various internal stakeholders and to discuss/present expert matters confidently.

Apply Now

More Job Searches

Germany      Clinical Research      Manager and Executive      Regulatory Affairs      Wörwag Pharma