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 CMC 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 specific questions and innovations regarding their area of expertise in cooperation with Head of Regulatory Affairs, US and Head of Global Regulatory CMC
- Development of customer-specific solutions and processes in cooperation with clients
- Build, develop and maintain working relationships with clients
- Support of new business development
- Collaboration in designing the division/department strategy with the Head of department/division
- Accountability for competent advisory service in their field of expertise
- Project management of complex projects
- Provision of appropriate expertise regarding area of expertise
- Advancements of processes and/or tools within defined area of expertise in collaboration with the Head of Regulatory Affairs
- Mentoring of employees within the department / division / company within departmental / divisional field of activity
- Gathering and sharing of experiences with regard to the area of expertise with focus on experience exchange, "Lessons Learned" and "Best Practice"
- Keeping updated in area of expertise
- Scientific support, guidance and coaching of team members
- Other duties as assigned
Required Education, Experience, Skills and Competencies
- Master's degree in pharmacy or other natural sciences and 8-10 years' experience; or equivalent combination of education and experience
- Extensive professional experience, broad/generalist knowledge spectrum in actual role
- Strong knowledge and experience with Regulatory Affairs US as well as submissions to the FDA
- 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 strategic goals for PharmaLex (e.g. contribution to BSC) as well as strategic goals of partnerships with clients (e.g. contribution to RfP responses for large outsourcing projects).
- 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 leading team members in difficult change management situations
- 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
- Full discretion to drive strategy and take action consistent with operating policies
- Ability to adapt under regularly changing conditions
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.