- Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
- Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC changes, identification of global regulatory requirements, and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
- Execute regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.
- Provide regulatory leadership as needed to product in-license/due diligence review, product divestment, and product withdrawal.
- Collaborate with our company's Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory milestones for assigned products across the product lifecycle.
- Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as needed.
- Bachelor's degree, in a science, engineering, or a related field - Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology or Biochemistry - with at least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph.D., PharmD) - minimum of 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.
- Preferred - degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline.
- Strong negotiation, interpersonal, written/oral communication and fluent in English language.
- Ability to lead by influence and work effectively in matrix organizational structures.
- Project Management.
- Good understanding of change management projects.
- Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem-solving.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, communication, interpersonal, and negotiating skills.
- Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
- A candidate with experience in Regulatory CMC post-approval lifecycle management is preferred.
- Direct experience in Regulatory CMC is preferred.
-
Accounting and Control Specialist
há 1 dia
Recipharm Lisboa, PortugalA Recipharm é uma CDMO (Contract Development and Manufacturing Organisation) líder na indústria farmacêutica, encontra-se atualmente a recrutar um Accounting and Control Specialist para substituição de Licença Parental. · **Responsabilidades**: · - Apoio no processo de fecho mens ...
-
Grupo Lusiaves Lisboa, PortugalO Grupo Lusiaves está à procura de um Responsável de Gestão de Planeamento Industrial para se juntar à nossa equipa. · Local de trabalho**:Aveiras de Baixo** · **Funções**: · - Assegurar a gestão do planeamento, programação e sequências de produção; · - Garantir o planeamento das ...
-
Quality Manager
há 1 semana
Amcor Lisboa, PortugalQuality Manager · **Location**:Lisbon, PT**Function**:Operations/Production/Manufacturing**Part-time or Full-time**:Full-Time**Job Type**:Employee**Workplace type**:On site**Join Amcor and you can be part of the team that makes the packaging of the future better for people and ou ...
-
Site Controller
há 3 dias
Solvay Lisboa, PortugalSolvay is a science company whose technologies bring benefits to many aspects of daily life. Our purpose—we bond people, ideas and elements to reinvent progress—is a call to go beyond, to reinvent future forms of progress and create sustainable shared value for all through the po ...
-
Quality Assurance
há 1 semana
Airbus Lisboa, PortugalWe are now looking for a Quality Assurance for our Airbus GBS team. · Responsibilities - your mission · - Conduct Process Failure Mode and Effects Analysis (PFMEA) · - Assess the quality of Process Failure Mode and Effects Analysis (PFMEA) according to Airbus criteria · - Perform ...
-
Foundever Lisboa, Portugal**Come and work with us.** · **Do you want to provide support for a leading manufacturer of drones, action cameras, and other products?** · Are you **Italian **native or fluent with strong communication skills? · Looking to make your career in a multicultural environment in sunny ...
-
French Customer Support Representative for A
há 1 semana
Foundever Lisboa, Portugal**Come and work with us.** · **Do you want to provide support for a leading manufacturer of drones, action cameras, and other products?** · Are you **French **native or fluent with strong communication skills? · Looking to make your career in a multicultural environment in sunny ...
-
German Customer Representative for a Leading
há 1 semana
Foundever Lisboa, Portugal**Come and work with us.** · **Do you want to provide support for a leading manufacturer of drones, action cameras, and other products?** · Are you **German **native or fluent with strong communication skills? · Looking to make your career in a multicultural environment in sunny ...
-
Employee CNC Polishing
há 1 semana
SwissOptic AG Lisboa, PortugalSwissOptic AG is part of the Jenoptik Group, a globally active photonics group with a presence in over 80 countries and around 4,900 employees. The basis of our business is optical technologies, which SwissOptic develops and manufactures in the form of sophisticated optical key c ...
-
Quality Assurance
há 4 dias
Airbus Lisboa, PortugalWe are now looking for a Quality Assurance for our Airbus GBS team. · Responsibilities - your mission · - Conduct Process Failure Mode and Effects Analysis (PFMEA) · - Assess the quality of Process Failure Mode and Effects Analysis (PFMEA) according to Airbus criteria · - Perform ...
-
Senior Program Manager
há 1 dia
Ferring Pharmaceuticals, Inc. Lisboa, PortugalJob Description: · At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women's health, gastroenterology and urol ...
-
Spanish Customer Support Representative for A
há 1 semana
Foundever Lisboa, Portugal**Come and work with us.** · **Do you want to provide support for a leading manufacturer of drones, action cameras, and other products?** · Are you **Spanish **native or fluent with strong communication skills? · Looking to make your career in a multicultural environment in sunny ...
-
Employee Conventional Spherical Polishing
há 1 semana
SwissOptic AG Lisboa, PortugalSwissOptic AG is part of the Jenoptik Group, a globally active photonics group with a presence in over 80 countries and around 4,900 employees. The basis of our business is optical technologies, which SwissOptic develops and manufactures in the form of sophisticated optical key c ...
-
Retail Display Project Lead
há 4 dias
Bose Lisboa, PortugalJob Description · Program Support Work 45% · 1) Planning/Admin · - Support Design/Build Vendor partner in execution of large display builds including consolidating commitments, securing Bose product, Part numbers and BOM's are obtained from the relevant internal resources. · - Re ...
-
Assembler Semicon Modules
há 1 semana
SwissOptic AG Lisboa, PortugalSwissOptic AG is part of the Jenoptik Group, a globally active photonics group with a presence in over 80 countries and around 4,900 employees. The basis of our business is optical technologies, which SwissOptic develops and manufactures in the form of sophisticated optical key c ...
-
Production Manager
há 5 dias
Zumub Lisboa, Portugal**ROLE**: · - Production planning and organization to meet the company's strategy and quality standards; · - Ensure the necessary materials to fulfill production orders and control costs; · - Monitor equipment maintenance and ensure that it is being done correctly; · - Work close ...
-
Cost Controller
há 2 dias
Ferring Pharmaceuticals, Inc. Lisboa, PortugalJob Description: · At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women's health, gastroenterology and urol ...
-
Continuous Improvement Assistant
há 1 semana
MAKEEN Energy SA Lisboa, PortugalIts mission will be to manage projects for the implementation and control of improvements based on the LEAN methodology in all areas of the company, promoting operational efficiency. Support the entire organization as an advanced expert in the improvement of processes and activit ...
-
Production Manager
há 5 dias
Zumub Lisboa, Portugal**ROLE**: · - Production planning and organization to meet the company's strategy and quality standards; · - Ensure the necessary materials to fulfill production orders and control costs; · - Monitor equipment maintenance and ensure that it is being done correctly; · - Work close ...
-
Quality Material Inspector
há 1 dia
DH Group - Recruitment & Building Lisboa, PortugalREAD, WRITE AND SPEAK ENGLISH IS MANDATORY · Job Description: · Performing inspection and supervision of the material delved on site in accordance with approved subcontractors ITP inspection points and related notifications and material preservation procedure. · Ensuring that sto ...
Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control - Lisboa, Portugal - Organon
Descrição
Job Description
The Position
The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations, and post-approval changes.
The incumbent may manage a team of one to two individual contributors and/or outsourcing partners in support of project execution. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as-needed basis.
Responsibilities
Required Education, Experience and Skills
Preferred Experience and Skills
OCMC
Secondary Language(s) Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
US and PR Residents Only
For more information about personal rights under Equal Employment Opportunity, visit:
Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.
Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Annualized Salary Range (US)
Annualized Salary Range (Global)
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%Flexible Work Arrangements:
Flex Time, TelecommutingShift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1