Description
Lead, manage and provide strategic direction to their regulatory team in assigned markets.
Manage assigned projects at a cluster level; provide strategic regulatory input into cross-functional product teams for pre- and post-authorisation product lifecycle activities working with above country operational hubs on operational activities.
Oversee strategy related to obtaining, managing and maintaining product Marketing Authorisations and support Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.
Cluster & Project Management
- Identify, implement and manage key regulatory cluster/country projects
- Lead implementation of effective and efficient processes in the cluster/country
- Monitor regulatory activities across product therapy areas
- Deputise for Head of Regulatory Sciences for the cluster/country as required
People and Resource Management
- Manage performance of direct reports
- Ensure regulatory team members work effectively in a productive and well-motivated environment
- Participate in the recruitment of new staff as required
- Ensure direct reports are supported and have a manageable workload
Deliver Regulatory Strategy and Advise Cross-Functional Teams
- Develop and deliver optimal regulatory strategies and plans
- Represent Regulatory on cross-functional product teams
- Facilitate cross-functional awareness and understanding of regulatory issues
- Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions
Provide Regulatory Advice and Information
- Provide insightful responses to enquiries from cross-divisional colleagues and external customers
- Advise on matters of compliance, regulatory requirements and Pfizer regulatory policy
- Use a variety of communication tools and techniques to present complex ideas
Manage New Registration/Marketing Authorization Applications
- Coordinate pre-submission meetings and other National Regulatory Authority (NRA) engagements
- Devise and obtain endorsement for submission strategy and plan
- Manage associated interactions and negotiations with NRAs
Manage Marketing Authorisation (MA) Variation Applications
- Trigger locally driven submission demands
- Input to assessing regulatory impact
- Work with above-country strategists and above-country operational hubs to supply country documentation
External Relationships
- Develop or enhance working relationships with Regulatory Authorities and trade associations
- Develop and enact influencing strategies
- Utilise local knowledge of NRA's expectations
QUALIFICATIONS / SKILLS
- Life sciences or chemistry graduate to honours level or equivalent
- Masters Degree, Post Graduate Diploma or PhD preferred
- Relevant Professional Qualifications desirable
- Previous experience and proven track record in Regulatory (Human Medicinal Products)
- Previous experience and demonstrated line management capability
- Computer literacy
- Excellent written and verbal communication skills, Fluency in English/Spanish required