Description
The successful candidate will- Define and implement regulatory strategies & deliverables for marketed products for the WE Area in alignment with the overarching global regulatory strategy, and in collaboration with the Regulatory Affairs personnel in the affiliates
- Represent the Area/Affiliate regulatory requirements and interests on the Global Regulatory Product Team to ensure those are met
- Develop a Local Regulatory Strategic Tactical Plan in collaboration with the Regulatory Affairs personnel in the affiliates
- Primary Regulatory Affairs interface with WE Commercial
- Primary interface to and from the Regulatory Affairs personnel in the affiliates
- Primary interface with local health authorities (via RA personnel in the affiliates): Responsible for direct liaison with EMA for assigned products within the Therapeutic area
- Manage the EU processes to achieve local HA input into R&D Programmes and regulatory approval
- Provide leadership and support to RA personnel in the affiliates
- Assess scientific data provided by specialist units for registration purposes against WE regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses (including CTAs)
- Maintain an active awareness of EU legislation and assess its impact on business and R&D programmes jointly with Regulatory Intelligence. Provide Area input on local implications through participation in Teams as needed Ensure regulatory compliance within WE for assigned compounds/products. Implement remediation plan to address any identified gaps
You will be expected to comply with the companys policies in order to meet statutory, quality and business requirements within the overall strategy and objectives.
You will be responsible for the health, safety and environmental performance of yourself and others through compliance within EHS programs, regulations and standards.
Desireable:
- Demonstrated ability to work independently with minimal supervision
- Extensive experience in EU Regulatory Affairs
- Strong leadership presence
- Demonstrated success in negotiating skills
- Understands business needs and impact of regulatory issues on these
- Strong interpersonal, managerial, organisational skills and teamwork
- Strong verbal and written communication skills
- A Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences subject