Senior Regulatory Manager
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Job Location:
Monthly Salary:
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Use Your Power for Purpose
At Pfizer were dedicated to bringing medicines to the world faster without compromising on excellence and integrity. Adhering to both local and global regulations is crucial and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your commitment and expertise are vital in expanding and accelerating patient access to Pfizers medicines and vaccines.
What You Will Achieve
In this role you will:
- Develop and lead innovative projects across the department and division creating comprehensive plans to meet objectives and manage complex projects.
- Formulate and implement regulatory strategies to support the registration of new products line extensions major variations and lifecycle management.
- Provide strategic contributions to country or cluster markets supporting leadership teams and fostering strong partnerships.
- Understand monitor and assess the impact of local regulations and trends in the regulatory environment on key stakeholders.
- Ensure compliance with local regulations by maintaining licenses implementing corporate regulatory processes SOPs and systems and ensuring team training.
- Provide support as needed to ensure the update of the Local Product Document (labeling) in line with relevant regulations and SOPs and in collaboration with the relevant hubs.
- Implement systems processes and procedures to enhance regulatory strategy productivity and facilitate information sharing across relevant lines; collaborate and define task distribution with the hubs.
- Deliver project/product strategies including label and risk assessments for assigned projects/products ensuring business compliance and adherence to regulatory standards.
- Develop and strengthen relationships with key external agencies to support the development and implementation of registration strategies
- Contribute actively to Trade Association projects working groups or task forces.
- Support line management to make decisions that require developing innovative solutions to resolve complex problems.
- Coaching and mentoring of less experienced colleagues and supervision of contractors (where applicable).
Here Is What You Need
- Life sciences or chemistry Masters degree; Post Graduate Diploma or PhD preferred.
- Relevant Professional Qualifications desirable (e.g. RIP certification courses in Regulatory Sciences etc).
- Previous experience and proven track record in Regulatory (Human Medicinal Products) of min 8 years.
- Deep understanding of both Regional and Global regulatory environments.
- Comprehensive knowledge of drug development practices rules regulations and guidelines.
- Strategic thinking and problem-solving skills.
- Experience in leading cross-functional teams.
- Proficiency in regulatory submission and approval processes.
- High level of attention to detail and organizational skills.
- Expertise and established experience managing strategic regulatory activities for development and marketed product portfolios.
- Proven project leadership skills.
- Excellent written and verbal communication and negotiation skills in Dutch French and English; knowledge of German is a plus.
- Proven strength in analytical thinking.
- Ability to manage multiple projects simultaneously.
- Demonstrable ability to supervise contractors.
- Proven ability to coach and mentor less experienced colleagues.
- Solid grasp of the business and financial environment.
- Computer literacy;Experience using common AI tools including generative technologies such as ChatGPT or Microsoft Copilot to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices includingrisk management and ethical use.
Work Location Assignment:Hybrid (some office presence is required)
Pfizer discovers develops manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story.
Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US) it is one of two Phase 1 Pfizer research centers in the world 2)Elsene the Belgian headquarters 3)Puurs Pfizers production and packaging site and 4) Zaventem the international Pfizers Logistics Center.
More information can be found atand on Facebook and Twitter.
Pfizers aim is to provide equality of opportunity in the recruitment process by avoiding any bias or potential discrimination on any grounds including (but not limited to): sex age race religion or belief sexual orientation or disability. At Pfizer we are creating an organization and promoting a culture that respects each individuals unique character and life experiences and reflects the diversity of our society customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Regulatory AffairsRequired Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
