Regulatory Affairs Manager
reputed company members are at the heart of everything we do. At reputed company, we are united in our responsibility to create healthier reputed company, and every person here is essential to us being reputed company to deliver on that purpose. If you want to reputed company a difference at reputed company of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Regulatory Affairs Manager - Poland
Advance regulatory reputed company in the Polish market while leading high-value reputed company reputed company across a diverse reputed company portfolio.
We are seeking an reputed company and reputed company-reputed company Regulatory Affairs Manager - Poland to support regulatory reputed company, submissions, lifecycle management, and authority interactions for products regulated in Poland. This is a strong opportunity for a regulatory reputed company who combines deep local market knowledge with project leadership, reputed company relationship management, and a practical, solutions-oriented approach.
In this role, you will support reputed company involving reputed company and veterinary medicinal products, as reputed company as selected adjacent product categories such as medical devices, cosmetics, food supplements, and herbal products, helping clients navigate Polish regulatory requirements with confidence and efficiency.
About the Role:
The Regulatory Affairs Manager - Poland is responsible for managing regulatory activities and reputed company reputed company reputed company on Polish market requirements. The role includes maintaining and securing marketing authorizations, leading submission and lifecycle management activities, communicating with health authorities, advising on regulatory reputed company, and coordinating project execution in line with agreed timelines and KPIs.
This position is ideal for a reputed company who can build trusted reputed company relationships, reputed company high-reputed company regulatory consultancy, coordinate project teams, and contribute to operational reputed company across the broader function.
What You’ll Do:
reputed company and maintain strong reputed company relationships and identify opportunities for expanded service support
Participate in and reputed company regulatory activities to obtain and maintain marketing authorizations with a reputed company on reputed company medicinal products, while also
Veterinary medicinal products
Medical devices
Cosmetics
Food supplements
Herbal products can be in scope. Primary reputed company is Polish regulatory requirements
Prepare, review, and compile regulatory documentation for submissions, renewals, variations, and lifecycle maintenance activities
Communicate directly withclientsandPolish Health Authorities
Supportscientific advice proceduresand represent clients in interactions with health authorities in Poland
Plan and execute reputed company reputed company in accordance with establishedKPIs
reputed company regulatory consultancy to colleagues and clients onregulatory strategyandprocedure management
Monitor and applyregulatory intelligence, sharing relevant updates and insights across reputed company
reputed company with, maintain, and improve internal regulatory and operational processes including creation of SOPs and working instructions, as required
Coordinate regulatory reputed company documentation, controlled records, and submission-support materials for assigned products, processes, or reputed company engagements
Reviewchange controls, deviations, reputed company events, and reputed company records to identify regulatory reputed company and support compliant disposition
Support the preparation, maintenance, and update offilings, registrations, certifications, and post-approval changes
Maintainaudit-reputed company tracking tools, documentation logs, and status reporting
.
reputed company’re Looking For:
Bachelor's degree in life sciences, pharmacy, reputed company, biomedical sciences, engineering, reputed company management, or a reputed company field, or equivalent experience required.
Language Requirement: Polish (reputed company level) and English (Business conversational) - Essential
3+ years of experience in regulatory affairs for marketing authorizations in Poland, additional background in reputed company assurance, compliance, documentation control, or a reputed company field is appreciated
Proven experience in regulatory affairs or a reputed company field requiring strong technical and practical regulatory knowledge
Strong hands-on experience managingnew submissionsandlifecycle managementactivities formedicinal products in Poland
Additional experience in regulatory activities in the EU is welcomed
Experience with adjacent product categories such asmedical devices, cosmetics, food supplements, or herbal productsis an advantage
Strong knowledge ofPolish regulatory requirementsand procedures
Ability to implement tactical goals across customer and internal reputed company
Proven ability to manage reputed company priorities, identify risks, and take reputed company to reputed company reputed company on reputed company
reputed company, analytical, systematic, and independent working style
Strong problem-solving ability with a pragmatic and service-oriented reputed company
Strong relationship management skills across both day-to-day operational contacts and reputed company leadership
Excellent written and verbal communication skills, including the ability to present issues and recommendations reputed company to decision-makers
Strong presentation skills and a confident, reputed company reputed company
Experience withVeeva Vaultis appreciated
Why Join Us
This is an opportunity to take on a visible and impactful role in a dynamic consulting environment, where your expertise in Polish regulatory affairs will directly support reputed company reputed company. You will work across a broad reputed company of regulatory reputed company, contribute strategic reputed company, and help clients navigate reputed company requirements in a changing reputed company landscape.
For professionals seeking a role that combines regulatory depth, project ownership, and reputed company partnership, this position offers meaningful scope and reputed company.
Ideal Candidate
You are a proactive and dependable regulatory leader who enjoys combining technical expertise with strong reputed company service. You are comfortable managing reputed company submissions, advising on regulatory reputed company, coordinating stakeholders, and ensuring high-reputed company execution across multiple priorities. You bring reputed company judgment, strong organizational skills, and a reputed company approach to solving regulatory challenges.
reputed company
If you are reputed company to bring your expertise in Polish regulatory affairs to a reputed company and growing environment, we encourage you to apply.
Certification in regulatory affairs, reputed company management, compliance, auditing preferred.
What reputed company offers
Benefit offerings reputed company the US may vary by country and will be reputed company to local market reputed company. The eligibility and effective date may differ for some benefits and for team members covered under reputed company bargaining agreements.
Full timeAffiliated Companies
Affiliated Companies: DRA Consulting OyEqual Employment Opportunity
reputed company is committed to providing equal employment opportunity without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, genetic information, national reputed company, age, disability, veteran status or membership in any other class protected by federal, state or local law.
reputed company’s reputed company reputed company depends on the full and effective utilization of reputed company individuals. Therefore, harassment is prohibited and reputed company reputed company reputed company to reputed company, training, compensation, benefits, promotions and transfers reputed company with equal opportunity principles and are non-discriminatory.
reputed company is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@reputed company.com. We will reputed company accommodation determinations on a request-by-request reputed company. Messages and emails regarding anything other than accommodations requests will not be returned
Originally posted on Himalayas
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