Regulatory Affairs Administrator

Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Interested to join our dynamic Pfizer’s Regulatory Affairs Belux Team that is dedicated to bringing Breakthrough’s that change patient’s lives to the Belgium and Luxembourg market? Then check this job opening within our team!

Regulatory Affairs Administrator

The purpose of this position is to allow Pfizer to legally study, manufacture, market and supply medicines by obtaining, managing and maintaining product Marketing Authorizations in line with business goals and legal requirements.

Your responsibilities

The Position:

• Ensure the accurate and timely maintenance of product information systems and databases, in line with local and global SOPs and procedures and with all applicable regulatory and legal rules and regulations, for the Pfizer Biopharmaceutical Belux portfolio.
• Support the delivery of change control processes linked to regulatory databases/systems and ensure timely notifications to stakeholders.
• Provide expertise to the team in operational processes and regulatory databases and systems, contribute to the implementation of projects and processes, contribute to building of processes and database/systems within the team and in global teams and projects.
   

Regulatory submissions and approvals – databases and systems :

• Provide administrative support for your assigned product portfolio as applicable for local regulatory submissions in collaboration with the Regulatory Strategists. , including assembly of documentation and preparation of “ready for submission” dossiers for the assigned marketing authorization applications and maintenance activities.
• Screen incoming correspondence from the Belgian and Luxembourg Agency or other external and internal stakeholders and take appropriate action, and/or liaise with the concerned Regulatory colleague to ensure proper action is taken.
• Ensure that all local and global regulatory systems, tracking tools and databases are continuously and accurately updated with regulatory information, in line with Pfizer local, regional and global procedures and with legal /regulatory requirements. Develop processes and coordinate routine and ad hoc QC checking of regulatory databases and systems and build expertise through management of operational processes and regulatory databases/systems.
• Act as super-user and system owner for defined regulatory databases/systems. Provide expertise to local and global teams in operational processes and regulatory databases and systems, and contribute to or take the lead in projects and workgroups on developing, building, implementing and optimizing processes and database/systems.
• Liaise pro-actively with global and regional groups and/or project leads to ensure that the needs of the Belux country organization are adequately represented when new initiatives impacting regulatory operations and/or databases are being developed and rolled-out for the region, or when needs for enhancement of existing systems is identified.
   

Artwork responsibilities:

• Coordinate artwork initiation, changes and follow-up for all packaging components for new and marketed products through the appropriate Global Artwork management systems and interact with the above-country hub for Artwork Implementation as required
• Discuss and define artwork needs in coordination with the Regulatory team members, and ensure the above-country hub for Artwork Implementation and/or plant are aware of the legal timelines for implementation and the local needs and requirements
• Pro-actively prepare Artwork Requests and Editor Copies as required, according to Pfizer procedures in coordination with the concerned Regulatory Affairs colleague(s), Logistics, and the manufacturing plants, and ensure appropriate QC has been performed.
• Maintain regular contacts with the above-country hub for Artwork Implementation and inform Regulatory colleagues on any potential impact on label text, artwork and/or product availability.
• In conjunction with the Regulatory Affairs Head, Team Leaders, Managers and/or Senior Associates, ensure the artworks are in compliance with current local legislation and Pfizer local/international policies on packaging
• Coordinate requests from regulatory team members for submissions artworks (mock-ups) as needed to ensure timely and complete regulatory submission
• Maintain the internal network on artwork development and approval
• Participate and implement the strategic decision related to the packaging development for new and marketed products in cooperation with Regulatory Affairs, the concerned Business Unit and the local Supply department, as well as Medical and Market Access/Health & Value, if applicable
• Ensure that the local artwork database is continuously and accurately updated to be available for the local Quality group and Regulatory team, and that local and global tracking systems are accurately and timely updated.
• Ensure that Country Requirements sheets for artwork centres at the manufacturing sites are kept up to date in the global system
• Actively participate to EU Artwork Subject Matter Expert Meeting with the Above-Country Artwork Hub bi-monthly
• Actively participate to the Artwork Community of Practise with the manufacturing sites in a monthly meeting
   

Your skills

• Bachelor degree in Management/(Medical) Secretarial Assistant, Life Sciences or equivalent, with relevant experience in Regulatory Affairs.

• Preferably 5 years of experience in the field of administration, secretarial work or office management, with previous experience and proven track record in a Regulatory Affairs environment (for Human Medicinal Products)

• Computer literacy: good knowledge on use of MS Word, Excel, PowerPoint, Outlook. Experience in using electronic document management systems and other electronic/digital tools.

• Languages: Fluent in written and spoken Dutch, French and English; notions of German are an asset

• Ability to communicate effectively verbally and in writing.

• Accurate, organised and problem solving, able to meet concurring deadlines

• Basic Project Management Skills

• Compliance minded

• Autonomous but with a strong team spirit

• Resilient

What you can expact:

At Pfizer, we invest in creating an environment which unleashes the power of our people. Some of our key drivers:

Diversity, Equity and Inclusion - Everyone has something to offer. We believe that a diverse and inclusive organization is crucial to building a successful organization. Pfizer is committed to celebrating this in all its forms ensuring we are as diverse as the patients and communities we serve.

When you grow, We Grow! - All colleagues are empowered to unleash their full potential, delivering on our company purpose through non-linear career paths, made of a diverse set of experiences.

Health & Wellbeing- We empower our colleagues to better care for themselves and make new investments to help them manage their mental and physical well-being. Ensuring an environment where colleagues can unleash their power and bring joy at work is one of our focus areas.

OUR OFFER

At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Pfizer's open-door policy is an integrated part of our culture across all levels of seniority.

We offer possibilities for working from home (up to 3 days per week) and flexible working hours.

Competitive salaries and benefit packages : meal vouchers, DKV hospitalisation, outpatient, dental, pension plan, phone, public transport reimbursement, …

Unparalleled opportunities for career growth: trainings, possibilities for internal mobility, temporary assignments…

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Interested? Click on the “apply” button! 

#LI-PFE 

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_, Pfizer's production and packaging site, and 4) Zaventem, the international Pfizer's Logistics Center._ 

More information can be found at www.pfizer.com, www.pfizer.be and on Facebook and Twitter. 

Regulatory Affairs