To prepare high quality CMC detailed regulatory documents using varied information sources. liaising closely with other company personnel to ensure accuracy of such records. Role...
To design and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds typically late development, marketed for the WE Area (including Israel, Turkey and Switzerland). Include fair representation of the interest of EU countries of EMEA in alignment with the overarching global regulatory strategy and region specific requirements.
- Identify and advocate region's requirements in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is taken into account at the GRPT.
- Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met. Duly reports on activities in these teams and alerts TA Head when necessary.
- Elaborate a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RA personnel in the affiliates. (Area Regulatory Product Team ARPT) to elaborate the region's position on specific projects.
- 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).
- Responsible for direct liaison with EMA for products within the Therapeutic area. Receives delegation to manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers.
- Provide leadership and support to RA personnel in the affiliates (through ongoing communication, assist in the development, training and mentoring of regulatory leaders).
- Assess scientific data provided by specialist units for registration (and re-r) purposes against WE regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses (including CTAs).
- Provide Area input on local implications through participation in Teams as needed (e.g., submission teams, labelling working group: development of labelling negotiations).
- Ensure regulatory compliance within WE for the assigned compounds/products. Implement remediation plan to address identified gaps, if any.
- A Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
- Confirmed pharmaceutical industry experience in Regulatory Affairs or R& D, with experience in Regulatory Affairs. European regulatory experience (including Israel, Turkey and Switzerland).
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.