Along with ManpowerGroup Solutions, we are seeking a candidate for the position of Senior Regulatory Affairs Professional-Analyst (M/K).

The Company we are recruiting for is a global leader in pharmeceutical innovations, specializing in innovative reasearch and clinical trials. As a global company they are representing international values and creating multicultural working environment. Seize this opportunity for work in a very well-known organization and join our client as a Senior Regulatory Affairs Professional/ Analyst!

Tasks:

Participating in Working groups to ensure timely regional and local input into product objectives, to align regions with CDT/global strategy
Working with the regional staff and LOCs to support regional and local activities
Assisting in the preparation of meetings with Regulatory Agencies
Assisting in the development of processes related to regulatory submissions
Drafting and reviews document content (depending on level of regulatory knowledge/expertise
Providing regulatory support throughout registration process and life-cycle management (e.g. iCTDs, ACTDs, renewal applications, Health Authority
Responding site registrations and routine marketed product submissions including PSURs, RMPs)
Advising team on required documents in preparation of submissions as assigned
Responsibility for the critical review of submission documents to ensure compliance with regulatory requirements

Required Skills and Qualifications:

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
Proven experience in regulatory affairs, specifically in global submissions within the healthcare industry
Strong understanding of international regulatory requirements related especially to submission requirements for lifecycle submissions e.g., protocol amendments,post-approval variations, annual reports, PSURs, DSURs, RMPs, renewal applications
Excellent organizational and project management skills with attention to detail
Awareness of competitive landscape, e.g., views of HA, regulatory precedence, labeling differences and product related issues
Effective communication skills in English, both written and verbal
Ability to work independently and collaboratively within a multidisciplinary team
Proficiency in regulatory software and document management systems
Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is advantageous

Offers:

Employment via ManpowerGroup Solutions based on an employment contract for 12 months
Flexible work arrangement: remote (outside Warsaw) or hybrid (Warsaw-based)
ManpowerGroup employment benefits including healthcare coverage
Additional perks such as a Sport Card to support a healthy lifestyle
Opportunities for professional development and career growth within a global organization
Supportive and inclusive work environment in Warsaw, Poland

Apply now to contribute to impactful projects and enjoy comprehensive benefits designed to enhance your professional and personal well-being. Join the team of our client and elevate your career in regulatory affairs today!

Employer: ManpowerGroup Solutions Sp. z o.o.

Praca GCP

Senior Regulatory Affairs Professional-Analyst (M/K)