Location: Switzerland - Meyrin/Geneva
Division: Regulatory Affairs
Company: OM Pharma
Seniority Level: Senior Manager
We are currently looking for an experienced Regulatory Affairs Team Lead who will lead key activities for EU, US and CH regions. You will be responsible for the definition and implementation of regulatory strategies based on the good knowledge and appropriate interpretation of guidelines and directives. Based in Geneva, you will report to the Head of Regulatory Affairs OM Pharma and your responsibilities will include:
- Contribute to the definition and the implementation of regulatory strategies to expand the business (geographic expansion, new indications…) and support/maintain registrations
- Coordinate life cycle activities / maintenance of existing product licenses
- Coordinate dossiers submission according to the defined timelines (renewals, variations, responses to HA questions)
- Ensure compliance of the portfolio with legal requirements
- Conduct risk assessments and set-up mitigation plans
- Cooperate with internal stakeholders to ensure alignment on strategies
- Lead the EU, US and CH regions team (2 direct reports): be responsible for the management and development of staff by overseeing recruitment and training, evaluating performance, defining and assigning responsibilities, providing opportunities for career development
We are looking for a customer- and service-oriented person who brings experience in working with a wide variety of stakeholders across diverse teams both internally and with external partner companies. The ideal candidate brings the following skills and experience:
- University Degree (PhD / MSc) in Life Sciences, Pharmaceutical Sciences or Medical
- 8 years of experience in Regulatory Affairs, within the EU region (support to clinical trials activities)
- Experience in people management and development
- Ability to perform comprehensive gap assessments and build effective regulatory strategies (Good knowledge and appropriate interpretation of guidelines, directives etc…)
- Self-assertion, creative and solution-oriented work approach
- Strategic thinking and acting, entrepreneurship skills
- Excellent communication and negotiation skills at all levels, diplomacy and respectful behaviour
- Regulatory Affairs experience in the US is beneficial
- Fluency language skills in English, language skills in French are preferable
You are a mature regulatory professional and describe yourself as a solution-oriented and flexible person, able to influence internal and external stakeholders. Your work is characterised by its accuracy, a proactive approach and you are able to work under pressure and to deal with tight deadlines. These skills will ensure your success in this role.
OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.