Regulatory Affairs Head
Vor 2 Tagen
Location: Meyrin, Geneva, CH- Division:
- Division: Regulatory Affairs- Job Type: Permanent roleWe are looking for a **Regulatory Affairs Head - SRAs & Development** based at our headquarter and production site in Geneva. Reporting to the Head of Regulatory Affairs and managing 5 people, your mission is to drive the Regulatory Affairs strategy and operations for what concerns development from early to late phase, expansion and lifecycle activities, at a global and regional scope in Stringent Regulatory Authority’s Countries.
Your main responsibilities are as follows:
- Lead the team and supervise Regulatory Affairs operations, in liaison with other Regulatory teams
- Timely plan and follow activities for regulatory development such as scientific advices and meetings with HAs for clinical regulatory activities (CTA, IND, Protocol Amendments)
- Review and ensure consistency of all scientific documentation from the development to the maintenance (Briefing books, IBs, Protocols, RMP, DSURS, BICs, CCDS, CTD sections etc.) according to internal procedures
- Define and implement regulatory strategy particularly for the EU/CH region, for US and for any SRAs market such as China and Australia in liaison with other Regulatory teams
- Budget and follow, from planning to execution, the activities of new registrations and maintenance of existing marketing authorizations: implement strategy and guidelines, set targets, manage Regulatory Affairs data, and assist the team for any issues they s may have
- Coordinate the Change control regulatory assessment for labeling changes for EU/CH/SRAs and support the one for CMC changes.
- Ensure compliance of the registered products to the legal requirements of the markets and to internal standards
- Represent the Regulatory Affairs SRA’s and Development team in meetings internally and externally
- Act as a business partner for the commercial organization and improve business performance by shortening time to market and speed of product change implementation
- Liaise with Stringent Regulatory Authority (SRA), affiliates and local partners (distributors)
- Work to increase the efficiency and effectiveness of the employees, processes, projects, and organizations as a whole and develop good regulatory practices
Business travels are required for this position, around 10% of working time.
To carry out this mission, we are looking for a person with the following profile:
- Degree in the field of Life Sciences (Master, Pharmacist or PhD), or equivalent educational background
- At least 7-10 years of experience in Regulatory Affairs in the pharma industry
- Strong understanding of Development activities from early phase I to late phase IV
- Proven track record of successful meetings with HAs such as EMA, FDA, NMPA, BfArM, MHRA and/or TGA. Experience both at the global and the regional level (particularly EU and US)
- Experience in direct people management
- Full fluency in English with good professional skills in French
- Proficiency in MS-Office tools
To be successful in this role, we are looking for a mature and reliable Regulatory Affairs leader with a good business acumen. You hold people management experience and truly enjoy coaching your teams to help them reaching success, fostering team spirit and proactivity. You describe yourself as solution oriented, flexible and able to take initiative to move things forward. Furthermore, your strategic thinking enables you to examine and understand issues from multiple points of view and work transversally with various internal and external stakeholders.
-
Clinical Regulatory Affairs Manager
vor 2 Wochen
Geneve, Schweiz AXEPTA VollzeitMy client, a global and growing biopharmaceutical company is looking for their new position as Regulatory Affairs Clinical Manager to join their team located in Geneva canton. Tasks **YOUR RESPONSIBILITIES**: - Be the main person in the regulatory affairs team regarding the clinical sections for regulatory submissions - Ensure regulatory tools to support...
-
Director Global Regulatory Affairs
vor 2 Wochen
Geneve, Schweiz coty Vollzeit**Title**: Global Director Fragrance Regulatory Affairs **Location**: Versoix, Switzerland PURPOSE Our purpose is to celebrate and liberate the diversity of beauty. We challenge convention through invention, expanding our horizons to enrich your reality with possibility. We build brands to inspire and enable our consumers to experience the confidence and...
-
Regulatory Affairs Assistant
vor 2 Wochen
Geneve, Schweiz bioMérieux sa VollzeitbioMérieux is present in 43 countries and serves more than 160 countries with the support of a_ _large network of distributors. Its corporate headquarters are located in Marcy l’Etoile, near Lyon,_ _France._ - Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed_ _to the service of public health and carried out...
-
Global Medical Affairs Lead
Vor 6 Tagen
Geneve, Schweiz Axepta SA VollzeitOur client, a growing and global biotech company located in Geneva canton is looking for a Global Medical Affairs Lead to manage a small team and work actively on the global medical affairs strategy for their key products. **YOUR RESPONSIBILITIES**: - Lead and manage a small team of Global Medical Affairs Managers - Ensure the global medical plan and...
-
Drug Safety Medical Manager
vor 1 Woche
Geneve, Schweiz OM Pharma Ltd. VollzeitLocation: Meyrin, Geneva, CH- Division: - Division: Drug Safety- Job Type: Permanent roleWe are recruiting a **Drug Safety Medical Manager **based at our headquarters in Geneva. Reporting to the Drug Safety Head, and working in close collaboration with the Clinical, Medical and Regulatory Affairs departments, your mission is to ensure Swiss and international...
-
Drug Safety Medical Manager
vor 1 Woche
Geneve, Schweiz OM Pharma Ltd. VollzeitLocation: Meyrin, Geneva, CH- Division: - Division: Drug Safety- Job Type: Permanent roleWe are recruiting a **Drug Safety Medical Manager **based at our headquarters in Geneva. Reporting to the Drug Safety Head, and working in close collaboration with the Clinical, Medical and Regulatory Affairs departments, your mission is to ensure Swiss and international...
-
Head of Client Relationship Management
vor 1 Woche
Geneve, Schweiz OPTIMA PARTNERS Vollzeit**Head of Client Relationship Management** For our client, a Geneva based bank active in Wealth Management, we are currently looking for a Head Client Relationship Management. In this role, your main objectives are to lead and motivate a team of Relationship Managers and Assistant Relationship Managers. You act as a role model and ambassador for the Bank....
-
Global Head of Storage
vor 2 Wochen
Geneve, Schweiz Trafigura Vollzeit**Main Purpose**: The Global Head of Storage will be responsible for managing the overall third party storage lease position for Trafigura, which currently has an overall expenditure of >$1B annually. **Knowledge Skills and Abilities, Key Responsibilities**: **Knowledge, Skills and Abilities** - Experience in the Energy terminals industry - Strong commercial...
-
Multilateral Adviser
vor 2 Wochen
Geneve, Schweiz Australian Embassy Vollzeit**Title**:Multilateral Adviser **Department**:Department of Foreign Affairs and Trade **Classification**: LE4 **Contract**:Permanent **Full-Time**:37 hours and 30 minutes per week **Salary**:CHF 92,431 per annum. 20 days annual leave, 14 days public holiday. 50% employer contribution to health and accident insurance and to a pension fund. Applications...
-
Head of Media Content
Vor 2 Tagen
Geneve, Schweiz World Economic Forum LLC VollzeitThe World Economic Forum, committed to improving the state of the world, is the international organization for public-private cooperation. The Forum engages the foremost political, business, cultural and other leaders of society to shape global, regional and industry agendas. The Global Communications Group is the central Forum team dedicated to...
