Similar posts
EMEA Regulatory Professional
- Permanent
- Project Manager
- United Kingdom
This vacancy has now expired. Please see similar roles below...
A vacancy has arisen for an experienced Regulatory Affairs professional, to take on the role as EMEA Regulatory Affairs Professional who can support the regional regulatory strategy for products in the oncology pipeline. They will be expected to use their previous knowledge to drive forward the regulatory team.
Job Responsibilities
- Participate in global regulatory team meetings as appropriate
- Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
- Act as back-up for contact with Regulatory Agencies as needed
- Draft cover letters for Regulatory Agency communication
- Assist in the preparation of meetings with Regulatory Agencies
- Liaise with LOCs, track and respond to queries in a timely manner
- Assist in development of processes related to regulatory submissions
- Draft and review some document content (depending on level of regulatory knowledge / expertise)
- Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
- Review protocols and ensure alignment with regulatory requirements
- Advise team on required documents and submission strategies in preparation of CTAs
- Ensure CTA submission packages are complete and available according to agreed timelines
- Provide regulatory support throughout registration process
- Provide regulatory support throughout life-cycle management
- Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
- Assist with submission and acceptance of MAA
- Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
Skills and Requirements
- University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Experience in regulatory affairs
- Teamwork experience
- Project management skills
- Oral & written communication skills
- Knowledge of the regulatory environment, guidelines and practice of EMEA regions
To Apply
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-PD1
Related jobs
Highly Competitive Salary
Palo Alto, USA
Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position.
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a Sr. Manager, Regulatory Project Manager for a leading pharmaceutical company. This is a contract position located in Cambridge, MA.
Highly Competitive Salary
Philadelphia, USA
Proclinical Staffing is seeking an Associate Director of Regulatory Affairs to join a top medical program.
Up to US$290000 per annum + Highly Competitive Salary
Boston, USA
Proclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization.
Up to US$225000 per annum + Highly Competitive Salary
San Francisco, USA
Proclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a cutting-edge AI company.
Highly Competitive
Cambridgeshire, England
Proclinical is seeking a dedicated and detail-oriented individual for the role of Project Manager Label Associate.
Highly Competitive
Reading, England
Proclinical is seeking a Regulatory Manager for a new role within the company.
Highly Competitive
Munich, Deutschland
Proclinical is on the lookout for a Senior Regulatory Affairs Manager. In this role, you will be responsible for developing and implementing regional regulatory strategies.