Regulatory Affairs Development Manager in Sottoceneri

veröffentlicht
Kontakt
Francesca Albini, Lugano
Jobtyp
Festanstellung
jetzt bewerben

job details

veröffentlicht
Ort
Sottoceneri, Tessin
Sektor
Life Sciences
Jobtyp
Festanstellung
Referenznummer
203430-6
Kontakt
Francesca Albini, Lugano
Telefon
+41 91 922 21 50

Stellenbeschreibung

On behalf of our estimated Client, first-class company operating in Pharma industry and leader in its field of activity, we are currently looking for a Regulatory Affairs Development Manager, in order to strengthen its structure.

This figure will report directly to the Corporate Regulatory Affairs Manager and supervise and mentor the Regulatory Team. She/He will also collaborate with the various internal functions external stakeholders (CMOs, commercial partners, etc.). Specifically, her/his main tasks and responsibilities will be linked (but not limited) to:

  • Establishing a strategy from development to registration and supporting the execution (directly and/or through supervising the operational resources) of the global regulatory affairs lifecycle and manage approved registrations through collaborating with the various internal and external stakeholders (CMOs, commercial partners, etc.)
  • Overseeing development projects and performing Due Diligence activities to evaluate regulatory risks and opportunities
  • Identifying in advance potential hurdles that might impact the regulatory success of development activities and/or potential licensing in processes
  • Supporting the Regulatory Corporate Manager in IND, NDA, and ANDA strategy preparation, involving and training the RA Team members responsible for operational activities
  • Providing operational support with strategic regulatory documents to help drive timely deliverables
  • Coordinating and driving team meetings to ensure quality and timely responses to health authority queries
  • Securing global submission plans together with the main area Project Manager and ensuring these plans can be executed on time
  • Supervising the marketing application submission team (EU/CH/US and RoW), helping to develop strategy and content for global dossiers
  • Translating regulatory requirements into practical workable submission plans
  • Supervising the resources currently managing patents and trademarks by navigating the relevant multiple legal domains in pharmaceutical research, development, and innovation
  • Remaining constantly updated on pharmaceutical regulations and sharing knowledge within the RA team members to promote their growth

Qualifikation

  • Solid scientific background (BSc, MSc, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine)
  • At least 10 years' experience in regulatory affairs preferably in global/HQ positions and/or across different geographic locations
  • Deep knowledge of drug development processes, European regulations, FDA regulations and procedures
  • Consolidated Experience in performing due diligence activities in early and late-stage product development (EU/US, mainly) and in pre-submission meetings with HAs (FDA, EMA and EU HAs) to define regulatory strategy for NDA, centralised, and decentralised procedures
  • Previous experience in intellectual property protection regulatory management in the pharmaceutical industry and in development and submission strategies for emerging countries (e.g., China, India, Russia, Brazil…) would be a plus
  • Excellent level of written and spoken English
  • Strong leadership skills, including the ability to set goals, provide constructive feedback, build positive relationships, and improve business results
  • Indirect or direct people management experience
  • Autonomous, efficient, proficient in project management, precise and detail oriented. Able to handle multiple projects with good prioritization skills
  • Confident in using Project, Excel, and Power Point to present project planning and Gantt charts

We offer full-time permanent employment inside a young work environment and great culture, along with appealing salary and social conditions.

If in line with the requisites and interested in discovering this opportunity, we will be glad to receive your complete application.