1+ months

Senior CMC Manager

Pfizer
Elsene
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. **Department**



GCMC is committed to support Biotherapeutic Pharmaceutical Science (BioTX PharmSci) and Global Supply (PGS) as competitive advantage for Pfizer by consistently delivering high quality regulatory strategies and timely submissions across product lifecycle.

GCMC is fully engaged in drug development, product line extensions and maintenance.

GCMC representatives participate on teams and at sites as GCMC experts and overall advocate for effective drug development and maintenance paradigms.

The person currently looked for, will be responsible for execution of Regulatory Strategies for Vaccines and Biotechnological Products.



**Responsibilities**



+ In order of importance, list the primary responsibilities critical to the performance of the position. It is recommended not to list actual tasks but focus on essential responsibilities that highlight accountability and level of judgment required.

+ Serves as a GCMC strategist for projects within product portfolios, providing regulatory assessments and developing regulatory strategies.

+ Acts as the CMC representative and contributes support to the Global CMC representative, within cross-functional project teams. Accountable for assigned projects and activities, independently completing work within assigned work group/project teams, for multiple projects.

+ Interprets CMC regulatory requirements, develop strategies (including novel approaches), assess risks and develops contingencies. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.

+ Responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.

+ Ability to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the Pfizer biopharmaceutical portfolio. Manages the resolution of regulatory CMC/information management issues with project/program stakeholders.

+ Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives.



**Skills**



+ Scientific degree in a relevant subject (minimum PharmD or science related BSc or MSc)

+ An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development and/or biopharmaceutical manufacturing and/or specific regulatory domain (5-7 years of prior international regulatory experience with 3-5 years in CMC). Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects.

+ Candidate is required to have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.

+ Leadership skills, influencing and persuading skills

+ Fluency in the English Language is essential

+ Strategic thinking and decision making

+ Excellent communication, interpersonal and relationship building skills

+ Collaborative team player

+ Excellent planning, organizational and project management skills

+ Problem solving skills to propose and assess regulatory solutions to CMC issues and prepare contingency plans will be helpful. Experience in medical device development and registration is useful.

+ Technical and scientific understanding of biopharmaceutical drug development with technical writing skills. May serve as Subject Matter Expert in specific relevant disciplines or recognized as a regulatory CMC resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains.

+ Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.



**We offer**



In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.

An exciting and challenging position that will inspire you and be changing your career path together with great colleagues based in our office in Brussels. You will be placed in an open and light office space where both interactions with colleagues and focused work are balanced.



\# LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Categories

Posted: 2019-07-10 Expires: 2019-11-20

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Senior CMC Manager

Pfizer
Elsene

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