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GRA Regulatory Strategist - EU, Senior Regulatory Manager

Job Description

  • Create and deliver strategic regulatory guidance for assigned projects/products.   Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines
  • Develop and implement Regulatory Strategies for assigned projects/products including assurance that project prioritization, submission strategies, labeling, approvals, post-marketing lifecycle management activities, etc., are in place and delivered in accordance with time, cost and quality expectations for all assigned projects.
  • Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies. 
  • Direct and/or indirect liaison with regulatory authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
  • Lead and/or participates in Regulatory Teams for assigned projects/products.
  • Develop and implements regulatory strategies to support/maintain registrations. Maintains product licenses across all product platforms.
  • Understand  regulatory environment and communicates priorities to global stakeholders
  • Deliver project /product strategy incl. label, risk assessment, and PRS for assigned projects/product

 

The major duties and responsibilities will include but are not limited to:

  • 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 communicated 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 sharing of information across the relevant lines.
  • Engages in appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.
  • Ensures business compliance and implementation of and adherence to Regulatory standards.
  • Develops and maintains constructive working relationship with Health Authority contacts.

 

Specialist Experience

  • Regulatory Knowledge: Knowledge of the regulatory environment and how this impacts regulatory strategy and implementation.  Understanding 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.
  • 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
  • B.S. Scientific Degree required.  An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.
  • Proven examples of delivery across the product’s lifecycle with demonstrable contribution in Regulatory Affairs.
  • Proven ability to manage complex regulatory issues.
  • Proven ability to consistently deliver to time, cost and quality Standards.

 

 

 

 

Please note that all information in this job description is accurate at the time of posting. Please be aware that companies may change details and/or closing dates without notice.

 

Job Summary

Company
Pfizer
City
Walton Oaks
Country
  • United Kingdom
Industries
  • Pharma/Biotech
Job Type
  • Full-time
Salary
  • Negotiable
Reference
GWP272516
Posted
25 February 2019
Applications Deadline
13 April 2019

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