A fantastic vacancy has become available for a Senior Regulatory Consultant in Surrey. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry.
- Contribute to Cross-functional Teams and Build Regulatory Expertise.
- In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
- Represent Regulatory Affairs on product based teams.
- Provide regulatory input to commercial strategic and operating planning process.
- Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary. Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.
- Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional Pfizer colleagues and direct or indirect interactions with external customers.
- Prepare agreed Module 1 documents in partnership with above-country operational hubs. Review supporting data and ensure that it complies with local regulatory requirements, agree filing strategy with other business functions as appropriate.
- Lead MRP submission review and planning where country is RMS, in conjunction with GRA strategist
- Manage and Submit MA Renewal Applications
- Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations.
- Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues.
- Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
- Respond to spontaneous requests from authorities promptly and accurately.
- Work with authorities if Pfizer position differs from authority position in order to obtain a better outcome for the business/patients
- Via defined procedures notify relevant internal customers of changes to packaging components and prescribing information the timelines for associated implementation activities.
- Prepare and submit application to discontinue product to Regulatory Authorities and notify intent to discontinue a medicine to the Ministry of Health. Act as liaison with Regulatory Authority/ministry of health.
- Contribute to and support as necessary, the maintenance and development of the Regulatory Affairs group through pro-active involvement and participation and in some instances, leading of special projects; e.g. development of new operating procedures.
Skill and Requirements
- Life sciences or chemistry graduate to honours level or equivalent
- Masters Degree, Post Graduate Diploma or PhD preferred
- Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)
- Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)
- Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred
- Computer literacy
- Excellent written and verbal communication skills
- Proven strength in analytical thinking
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