Our client a Global Pharmaceutical Company have opened a new vacancy within their Regulatory team and are looking to recruit a Regulatory Consultant to be based in their offices in Berkshire on an initial 12 month contract.
- Define and implement Area & Affiliate regulatory strategies & deliverables for development compounds and marketed products in the defined Therapeutic Area for the EEMEA Area (including Russia, CIS, CEE, Adria, Middle East and Africa). In alignment with the overarching global regulatory strategy and in collaboration with the RA personnel in the affiliates.
- Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met.
- Develop a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RA personnel in the affiliates utilising the Area Regulatory Product Team (ARPT) meetings.
- Primary RA interface with Commercial. Represent RA on the Brand Teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product).
- Provide leadership and support to regulatory affairs employees in the affiliates through ongoing communication and assisting in the development, training and mentoring of regulatory leaders.
- Assess scientific data provided by specialist units for registration (and re-r) purposes against EU and EEMEA regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data and development of complete and timely responses.
- Maintain an active awareness of EU and EEMEA legislation and assess its impact on business and R&D programs jointly with Regulatory Intelligence. Develop and execute strategies to respond to those. Propose revisions. Ensure application of policies once established.Provide Area input on local implications through participation in Teams as needed (e.g., submission teams, labeling working group: development of labelling negotiations).
- Ensure regulatory compliance within EEMEA for assigned compounds/products and implement remediation plan to address identified gaps, if any.
Qualifications & experience:
- A number of years pharmaceutical industry experience in Regulatory Affairs or R& D, with experience in Regulatory Affairs. European and EEMEA Area regulatory experience (including Russia, CIS, CEE, Adria, Middle East and Africa) is a must
- Experience working effectively across cultures and in complex matrixed environment.
- Strong project manager, excellent organisational skills and solution driven style.
- Proactive verbal and written communication style at all levels.Ability to work independently with minimal supervision.
- Strong interpersonal, managerial and organizational skills.
- Understands business needs and impact of regulatory issues on these
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