Regulatory Affairs Executive
Full Time
full time
6 Sep 2024
Verified by Turrior
Content + Source + Freshness • 16 Dec 2025 • 95% confidence
80 / 100
Offer value
The position provides a competitive salary with vital responsibilities in regulatory submission processes, suited for early to mid-career professionals.
- Competitive salary with growth opportunities
- Diverse experience in regulatory submissions
- Exciting environment for entry and mid-level professionals
- Focus on collaborative work
Pros
- Strong potential for skill development in regulatory affairs
- Diverse tasks contributing to regulatory submissions and compliance
- Supportive work environment for professional growth
Cons
- Less autonomy compared to managerial positions
- Possibility of high workloads during submission deadlines
- Requires a graduate-level education or equivalent experience
Who it's for
Entry to Mid-Career • Office based
Good fit
- Candidates with degrees in relevant scientific fields
- Collaboration-oriented individuals
- Regulatory affairs professionals eager to learn
Not recommended for
- Inexperienced candidates without relevant education
- Those who prefer managerial roles
- Individuals seeking fully remote employment
Motivation fit
Interest in regulatory processes and product complianceDesire to develop documentation and communication skillsAiming for a career path in the regulatory sector
Key skills
Regulatory compliance knowledgeDocument preparationInterpersonal communicationOrganizational skills
Score: 80/100 AI verified analysis
About the job
Salary:
Competitive
Job Timings:
8 AM to 5 PM
Requirements:
Graduation in pharmacy background or any relevant degree.
About the role:
- To contribute to the regulatory documents and reports to be included in regulatory submission.
- Documents and track regulatory submission and regulatory authority license approval for EU market and most probably Germany.
- Provide regulatory support to the teams and associates of the company.
Responsibilities:
- Application for new registration to receive license from EMA.
- Cooperation with authorities (e.g. BfArM, PEI, EMA, EC).
- New registrations/manufacturer sampling electronic PI submissions.
- Create sample packaging (outer packaging, labels, package insert).
- Create manufacturing instructions as per EU legislation and receipt of approval from MAH.
- Maintenance of existing approvals and maintaining formats and content review of packaging texts, SmPC, PIL and labelling.
- Review task for, support and mentor Regulatory Affairs associates.
- Provide on-going regulatory support to the regulatory affairs team lead and to project teams to ensure regulatory concerns are planned and accounted for the relevant data are generated to meet project objectives.
- Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflet and labelling.
- Contribute to data entry in softwares, Control that invoicing is correctly done.
- Assist the RA platform or hub leader or Coordinator in presales.
Candidate Requirements:
- Master’s or higher graduate degree in a science related field.
- Strong coordination skills and leadership.
- Excellent organizational and interpersonal skills.
- confident use of MS Office and Multi-tasking.
- Effective oral and written communicational skills.
- Proactive attitude and able to work on own initiative as well as part of team.
- Ability to prioritized different workloads/multi tasks.
- Personal responsibility for ensuring a high standard of work.
Benefits:
- Competitive salary and performance-based incentives.
- Comprehensive benefits package including health insurance.
- Opportunities for career growth and advancement within a global organization.
- Dynamic and collaborative work environment with a diverse and inclusive culture.
