Regulatory Affairs Development Manager

Healthcare (Operations)
For our estimated client we're hiring Regulatory Affairs Development Manager.

Essential tasks and responsibilities:

With the support of the Regulatory Affairs Team and with the aim of promoting the team members' individual growth, the responsibilities include:

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.

Required skills and core competences:

Solid scientific background (BSc, MSc, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine).
At least 15 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.