Senior Regulatory Affairs Manager
An exciting opportunity has arisen at a leading biopharmaceutical organisation with extensive experience in discovering, developing and manufacturing innovative human therapeutics. The opening is for a Senior Regulatory Affairs Manager position at their base in Uxbridge. This a truly exciting opportunity to work with a global company with over 17,000 employees worldwide.
- Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the company's portfolio in compliance with global filing plans and local regulatory requirements.
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Leads development of regional regulatory documents and meetings in accordance with GRT strategy.
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use, and paediatric plan).
- Directs the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Manages regional label negotiation activities.
- With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives.
- Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs).
- Communicates regulatory strategies as appropriate such that expectations are understood.
- Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management.
- Develop predictions for expectations and risks associated with outcomes by regulatory agencies.
- Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments).
- Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations.
- Communicate and ensure alignment of regional management before GRT strategy decisions.
- Partner with regional management and peers to ensure consistency in procedures and agency interactions.
- Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to company products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Evaluates and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labeling.
- Act as contact and create relationships with agency staff on specific product assignment.
- Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management.
- Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy-includes contingency regulatory planning/risk assessment.
- EU: Review and approve promotional and non-promotional materials for use in international region.
Skills and Requirements:
- Demonstrable experience or education in a similar or relevant field.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Peter Duvall at +44 203 078 9542 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.
Proclinical Staffing is an equal opportunity employer.
£0.00 - £45 per hour
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