PharmaLex is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asian offices, we provide integrated drug development services through a complete range of offerings including regulatory strategy and operations, quality management and compliance, pharmacovigilance and life-cycle management. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.
We are currently looking for a Director, Principal Consultant, Regulatory Informatics & Operations to support our REG team. Candidates should be dependable self-starters who bring with them a high level of ownership over their work, an enthusiastic attitude and a collaborative mindset to support our efforts to provide regulatory and development consulting solutions for pharmaceutical and biotech companies of all sizes.
This position can be based in our Burlington, MA office or fully remote with travel as necessary. General travel expectations post-COVID will be up to 20%.
As a Key Contributor You Will deliver high-level consulting to clients and colleagues using a broad field of expertise while managing complex CMC projects.
Key Responsibilities and Activities
- Consulting of clients regarding Regulatory Operations, electronic submissions, and technology innovations regarding his/her area of expertise
- Scoping, implementation, maintenance, and further development of global regulatory systems at PharmaLex in close collaboration with Head of Regulatory Operations, IT and other stakeholders
- Supporting business development activities in the field of regulatory systems, standards, and related processes
- Supporting client system audit or a GxP inspections in close collaboration with the Head of Regulatory Operations and Quality Management
- Consulting of clients regarding Regulatory system questions and innovations in cooperation with other stakeholders
- Development of customer-specific solutions and processes in cooperation with clients
- Build, develop and maintain working relationships with clients
- Accountability for competent advisory service in field of expertise
- Lead large and/or complex project teams; take over management of the overall project management
- Collaborate in designing the division/department strategy with Head of the department / division as well as define strategic goals of partnerships with clients (e.g. contribution to RfP responses for large outsourcing projects)
- Support of marketing, business development and sales activities
- Improvement of processes and/or tools within defined area of expertise in collaboration with the Head of Regulatory Affairs US
- Mentoring of employees within the department / division / company within departmental / divisional field of activity
- Other duties as assigned
Required Education, Experience, Skills and Competencies
- Bachelor's Degree in related field and 8-10 years' experience; or equivalent combination of education and experience
- Broad knowledge in the field of Regulatory Operations and Regulatory information and system management
- Strong knowledge and experience with Regulatory Affairs US as well as submissions to the FDA
- Experience in defining and implementation of new system strategies, standards, and related processes
- Deep understanding of regulatory landscape, esp. in regards of systems, standards, and related processes
- Strong knowledge about IT systems and databases as well as related technologies
- Drives solutions to complex problems impacting company success
- Experience in adjacent areas of expertise or willingness to broaden the knowledge/to build up knowledge in complementary fields of expertise
- Ability to define and convey strategic goals for PharmaLex Regulatory systems as well as strategic goals of partnerships with clients and stakeholders
- Ability to lead large international and/or complex project teams and
- Ability to balance client requests and company interests
- Ability to analyze and solve problems and to develop pragmatic solutions at higher (e.g. company) level
- Ability to lead large international and/or complex project teams, supporting and coaching team members in difficult change management situations and achieving commitment according project milestone
- Ability to manage client relationships on VP level and to convey strategic goals of collaboration
- Proven capability to communicate critical issues and proposed solutions to senior management levels; ability to successfully manage stakeholders even in critical or sensitive situations
- Ability to adjust rapidly to new, unknown, challenging situations
- Full discretion to drive strategy and take actions consistent with operating policies
- Ability to adapt under regularly changing conditions
- Very good command of English, written and verbal
- Outstanding organization, analytical, and problem-solving skills
- Excellent written, verbal and presentation communication skills
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Ms / Mr Emmerth
Director Human Resources
Agencies only by prior agreement for the specific job opportunity.