Senior Consultant, Regulatory Sciences

Company Description
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

**Job Description**:
The Senior Consultant, Regulatory Sciences role is client facing. The consultant’s input spans across the following core business processes:

- Client management, oversight of client work (including workload allocation and project resourcing) and delivery of assigned projects.
- Regulatory Activities including:

- Authoring complex technical documentation for regulatory submissions.
- Regulatory strategy and decision making.
- Supporting PIL user testing activities through the preparation of testing protocols and study reports.
- Quality control (QC) regulatory documents and/or submission dossiers.
- Regulatory dossier audits (as required).
Line management (where required).
- Training (regulatory & technical) of direct reports or the wider group (as required).
- Business development support (as required).
- Deputising for the Managing Consultant (as required).

Essential Functions Include:
Client Management, Oversight of Client Work & Delivery of Assigned Projects
- Develop and maintain excellent client relationships through timely and effective communication, active listening and constructive dialogue with the client.
- Monitors his/her invoiceable performance metrics and those of any direct reports in line with agreed targets.
- All projects should be delivered to deadlines agreed with the client. Issues that threaten project delivery should be discussed with the Group lead and the client.
- Ensure the allocated projects are completed within the agreed budget. Responsible for escalating any issues proactively.
- Responsible for confirming the billable hours for the allocated projects to the Accounts team at the end of each month.
- Weekly workload updates with the Managing Consultant and/or Head of Regulatory.
- Deputise for the Managing consultant (as required).

Regulatory Activities
- Authoring complex technical documentation for regulatory submissions, preparing regulatory dossiers or providing constructive regulatory feedback to clients on documents prepared outside of ProPharma Group.
- At times this might require the Senior Consultant to use his/her knowledge and experience to navigate through complex regulatory landscapes.
- Understand, review and initiate regulatory strategies and discuss these through with their line manager and the client where relevant.
- Supporting PIL user testing activities through the preparation of testing protocols and study reports.
- Quality control (QC) regulatory documents and/or submission dossiers of peers or direct reports, as required.
- Regulatory dossier audits (as required).

Line Management
- Regular 1:1s with direct reports.
- Ensuring urgent work activities can be re-allocated as required in cases of staff sickness.
- Reporting any staff welfare issues to the Managing Consultant.
- Reporting any information security issues to the Managing Consultant.
- Reporting any performance issues to his/her line manager.
- Agreeing any deviations to the company’s standard working hours with direct reports.
- Agreeing staff Learning and Development plans with direct reports.

Business Development (if required)
Understanding client requirements and translating this into contract proposals that fit client needs.

**Qualifications**:

- Graduate with a degree in the life sciences, chemistry or biochemistry.
Minimum 5-7 years of experience in regulatory affairs within biotech, pharmaceutical industry or government agency is a requirement.
- Proven experience of completing complex regulatory projects and submissions.
- Extensive experience in authoring technical and administrative documentation for regulatory submissions.
- Extensive knowledge of European regulatory procedures.
- Experience of leading interactions with regulatory agencies.
- Ability to maintain high quality, accuracy and consistency in your work and deliver on your commitments.
- Positive attitude and ability to work well within a team.
- Ability to work independently with less supervision, take initiative and make decisions based on company guidelines.
- Ability to work on multiple projects, prioritize and meet project deadlines.
- Excellent communication skills (verbal and written), both externally (with clients and authorities) and internally.
- Ability to tr