Regulatory Consultant - Emerging Markets

Here is an exciting pharmaceutical job one of the industry's most prestigious organisations. There is a vacancy for a Regulatory Consultant to join a global top 10 pharmaceutical company at their offices located in Surrey UK.

Job Responsibilties:

• Create and deliver strategic regulatory guidance for assigned projects/products, within Emerging Markets.
• Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines
• Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies
• Works directly or indirectly with external contacts in Health Authorities within assigned portfolio, as well as with relevant experts and key opinion leaders
• Collaborate with regional and local regulatory colleagues to facilitate the prompt review and approval of applications, supplements, and commitment closures
• Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products
• Develop and implement regulatory strategies to support/maintain registrations. Maintain product licenses across all product platforms
• Understand regulatory environment and communicate priorities to global/regional stakeholders
• Deliver project regulatory strategy, risk assessment, and PRS for assigned projects/products
• Reports to GEP RA Brands Cluster Lead
• Partners with other Regulatory Strategists and GEP RA Brands CMC team to assure consistent and appropriate regulatory support
• Partners with other relevant GEP R&D and WSR/WRD colleagues and relevant project team(s) members from other partner lines (i.e. Safety, Commercial, Medical/Clinical, DSRD, Pharmaceutical Sciences, Legal, etc.).to achieve objectives
• Accountable for ensuring or contributing to Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned projects
• Management and tracking of lifecycle management and/or growth activities for products within the TA; coordinating and /or preparation of Agency communications, participate and/ or lead RRTs in support of activities such as, Agency queries, drug shortages and/or Area Quality Review Team activities.
• 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., Brand Teams) to ensure required regulatory contributions (line plans, IND, NDA and Global Regulatory Strategy documents) meet business needs and are provided to the project teams, to agreed time, cost and quality standard
• 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 projects, and that these regulatory positions supporting the business are championed and communicated
• 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

Skills and Requirements:

• 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
• 5 years regulatory experience preferred
• Regulatory knowledge of Emerging Markets submissions processes and regulatory environment.
• Regulatory knowledge of NDA/IND, 505(b) (2) submission processes
• Experience managing multiple products simultaneously and different stages of the product lifecycle
• Experience in successfully communicating with major Health Authorities, including leading and participating in such interactions
• Proven ability to consistently deliver to time, cost and quality standards
• Strong written and verbal communication skills

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.