The Role: To implement Area & Affiliate regulatory strategies & deliverables for my clients Immunology Portfolio typically late development, marketed for West Europe. Include fair...
To implement Area & Affiliate regulatory strategies & deliverables for my clients Immunology Portfolio typically late development, marketed for West Europe. Include fair representation of the interest of EU countries of EMEA. In alignment with the global regulatory strategy and region specific requirements.
Implement regulatory strategies & deliverables typically for late development and marketed products within Immunology for Western Europe.
Receive delegation to represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team to ensure those are met.
Duly reports on activities in these teams and alerts his/her management when necessary.
Propose a Local Regulatory Strategies in collaboration with the RA personnel in the affiliates.
Provide strategic input for registration, to ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations.
Primary interface to and from the RA personnel in the affiliates.
Primary interface with local health authorities including direct liaison with the EMA.
Provide leadership and support to RA personnel in the affiliates
Assess scientific data provided by specialist units for registration purposes against regional regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses including CTAs.
Implements the EU processes to achieve HA input into R&D Programmes and regulatory approval.
A Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required
Pharmaceutical industry experience in Regulatory Affairs or R& D, with experience in Regulatory Affairs. European regulatory experience preferred.
Experienced working across Immunology products within Lifecycle Management and MAA Submission desirable.
Hands on experience managing Centralised Procedure submissions essential
Experienced in communications with the EMA to obtain scientific advice including preparation and questioning.
Ability to working within a matrix team including locally and internationally.
Percent of Travel: 25% at least.
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 589626
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.