GRA Global Regulatory Strategist - Manager - Flexible Working Available
What You Will Achieve
You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting directly/indirectly with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines.
Your knowledge of regulatory procedures will help in development of submission of product registration, progress reports, supplements/variations and periodic experience reports. You will have an comprehension of the regulatory environment and will communicate priorities to global stakeholders
As a Manager, you provide guidance to operational teams for managing projects. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate concords between different teams.
How You Will Achieve It
- Accountable for ensuring or contributing to Global/Regional Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.
- Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards and minimize resource demands while maximizing overall project delivery time and probability of success and facilitating post filing activities.
- Partners with project teams and other customer groups (e.g., Country Regulatory Managers, Brand Teams, PGS, etc.) to ensure required regulatory contributions (e.g. briefing documents, line plans, IND, NDA) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.
- Ensures regulatory plans are monitored, progress/variance conveyed to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
- Ensures an aligned regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the business are championed and communicated.
- Works closely with other Regulatory and CMC Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learning's and quality standards.
- Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the imparting of information across the relevant lines.
Required Qualifications, Skills and Experience
- Bachelor's Degree essential, Master's degree desirable
- Demonstrable experience of effective delivery in a complex matrix environment
- Regulatory Knowledge: Knowledge of the regulatory environment and how this impacts regulatory strategy and implementation. Comprehension of regulatory agency philosophy and guidelines. Experience preparing and submitting MAAs, line extensions, NDAs, INDs. Working with and influencing, opinion leaders, external organizations facilitating approval of submissions.
- In depth knowledge of national/regional regulatory legislation and guidelines.
- Therapeutic Area Knowledge: Has working knowledge of the therapeutic area, through prior regulatory experience; direct product development and/or academic training.
- Commercial Awareness: Demonstrated knowledge of global regulatory procedures and requirements. Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting MAAs and post approval variations.
- Problem Solving and Analysis: Strong problem identification and solving skills, e.g. risk management planning. Strong logical and analytical skills.
- Communication skills: Communicates effectively using a variety of mediums appropriate to the setting.
- Negotiation skills: Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations.
- Proven examples of delivery across the product's lifecycle with demonstrable contribution in Regulatory Affairs.
The closing deadline for applications is January 4th 2021.
All applicants must have the relevant authorisation to live and work in the UK.