Corporate Drug Regulatory Affairs Manager

CareerWise Recruitment; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

BASE, based in North Dublin, seeks a Corporate Drug Regulatory Affairs Manager for a 12-month temp contract. The role bridges the company with global health authorities to ensure safe, compliant market authorisations. Hybrid work involves 3 days on-site; minimum Stamp 4 is required.

Responsibilities include global submissions, licensing strategies, cross-functional collaboration, and regulatory and QA support. Strong English and regulatory systems knowledge are essential.

Qualifications

• University degree in natural sciences (Biology, Chemistry or Pharmacy) required.
• Knowledge of essential regulatory requirements.
• Ability to plan and execute regulatory projects globally.
• Excellent communication skills and team player mentality.
• Excellent English language skills.
• Proficiency with standard software (MS Office).
• Preferable knowledge of regulatory systems (DMS, CCS, RIMS).

Responsibilities

• Handle marketing authorization application procedures (new submissions, variations, renewals) worldwide.
• Prepare and discuss licensing strategies with national and international authorities.
• Collaborate in regional/global cross-functional projects.
• Review, prepare, coordinate and process regulatory documents (CTD module 1).
• Review and coordinate quality documentation (CTD modules 3/2.3).
• Coordinate clinical and non-clinical documentation.
• Support QA activities (change control, PQR) and pharmacovigilance tasks (RMPs, PSURs).
• Utilize electronic systems (DMS, Change Control System, RIMS, etc.).

Skills

Regulatory knowledge

Project planning

Communication skills

Team player

English language proficiency

MS Office

Regulatory systems knowledge

Education

University degree in natural sciences

Tools

MS Office

Regulatory systems (DMS/CCS/RIMS)

Job description

Job DescriptionA

Job DescriptionA Corporate Drug Regulatory Affairs Manager - on a 12-Month Temp Contract - is required by CareerWise Recruitment for our client BASED in North Dublin. The Manager of Corporate Drug Regulatory Affairs serves as the vital link between the company and global health authorities to ensure medicines are safely and legally brought to market. This corporate leadership role oversees the planning, preparation, and submission of global marketing authorization applications while managing lifecycle variations to maintain product compliance worldwide. HYBRID - 3 days per week on-site, must have Minimum Stamp 4! !

Role of this position

• Handling of marketing authorisation application procedures (e.g. new submissions, line extensions) worldwide, as well as registration maintenance activities (e.g. variations, renewals)
• Preparation and discussion of licensing strategies with national and international authorities
• Collaboration in regional / global projects in Cross functional teams
• Review, preparation, coordination and processing of regulatory documents (CTD-module 1)
• Review and coordination of quality documentation (CTD – module 3 / 2.3)
• Coordination of clinical and non-clinical documentation
• Support of QA activities (e.g. change control, PQR), drug information and
• pharmacovigilance related activities (e.g. Risk Management Plans, Company Core Data Sheets, PSURs)
• Use of electronic systems like Documenten management system, Change Control System, Regulatory Information Management System, etc.

Job Requirements

• University degree in natural sciences, i.e. Biology, Chemistry or Pharmacy
• Knowledge of essential regulatory requirements
• Ability to plan and execute regulatory projects globally
• Excellent communication skills, a real team player
• Excellent skills in English language
• Knowledge of standard EDV programs (e.g. MS-Office)
• Preferable knowledge in common regulatory systems (e.g. DMS, CCS, RIMS)