Senior Scientist, Regulatory Chemistry

2 semanas atrás

Lisboa, Portugal Organon Tempo inteiro

**The Position**

Reporting to the Lead of the Dermatology Product Portfolio in Organon Regulatory CMC, the Sr. Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations, guidance and defined regulatory strategies. The Senior Scientist is responsible for the preparation and review of the information required for the development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but are not limited to:
**Responsibilities**
- Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify 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.
- Liaise with Organon Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory milestones for assigned products across the product lifecycle.
- Identify and communicate potential regulatory issues to Organon Regulatory CMC management, as needed.

**Required Education, Experience, and Skills**
- Bachelor’s Degree, in a science, engineering, or a related field. Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry with at least 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR
- Advanced degree (MS, MBA, Ph.D., PharmD) with at least 2 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field
- Direct experience in Regulatory CMC is preferred

**Preferred Education, Experience, and Skills**
- Experience in reviewing 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 oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
- Demonstrated effective leadership, communication, and interpersonal skills.

Relocation assistance is not provided for this position.

**Secondary 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.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Annualized Salary Range (Global)**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

**Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites**

10%

**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R524031

  • Senior Scientist, Regulatory Chemistry

    2 semanas atrás

    Lisboa, Portugal Organon Tempo inteiro

    **The Position** Reporting to the Lead of the Dermatology Product Portfolio in Organon Regulatory CMC, the Sr. Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations, guidance and defined regulatory strategies. The...

  • Associate Principal Scientist, Regulatory

    Há 1 mês

    Lisboa, Portugal Organon Tempo inteiro

    Reporting to the Established Brands Dermatology Portfolio lead in our Company's Regulatory Chemistry, Manufacturing & Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule or biological products in accordance with global regulations and guidance's, and Company...

  • Associate Principal Scientist, Regulatory

    Há 3 horas

    Lisboa, Portugal Organon Tempo inteiro

    **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...

  • Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control

    3 semanas atrás

    Lisboa, Portugal Organon Tempo inteiro

    Job DescriptionThe PositionThe 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...

  • Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control

    2 semanas atrás

    Lisboa, Portugal Organon Tempo inteiro

    Job DescriptionThe PositionThe 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...

  • Senior Scientist, Safety Analysis Scientist

    Há 1 mês

    Lisboa, Portugal Johnson And Johnson Tempo inteiro

    Essential Job Duties and Responsibilities The Senior Scientist Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The Senior Scientist SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required...

  • Senior Scientist, Safety Analysis Scientist

    Há 1 mês

    Lisboa, Lisboa, Portugal J&J Family of Companies Tempo inteiro

    Senior Scientist, Safety Analysis Scientist WDescriptionEssential Job Duties and ResponsibilitiesThe Senior Scientist Safety Analysis Scientist (SAS) provides scientific expertise and leads the safetyassessment of assigned products. The Senior Scientist SAS, in partnership with the Medical SafetyOfficer (MSO), is responsible for the preparation of scientific...

  • Senior Scientist, Safety Analysis Scientist

    2 semanas atrás

    Lisboa, Lisboa, Portugal J&J Family of Companies Tempo inteiro

    Senior Scientist, Safety Analysis Scientist WDescriptionEssential Job Duties and ResponsibilitiesThe Senior Scientist Safety Analysis Scientist (SAS) provides scientific expertise and leads the safetyassessment of assigned products. The Senior Scientist SAS, in partnership with the Medical SafetyOfficer (MSO), is responsible for the preparation of scientific...

  • Senior Data Scientist

    3 semanas atrás

    Lisboa, Portugal Xcede Tempo inteiro

    **Senior Data Scientist**: - Location: - Lisbon- Salary: - €50000 - €70000 per annum + benefits- Job Type: - Permanent- Date Posted: - about 4 hours ago- Expiry Date: - 28/06/2024- Job Ref: - BBBH110084_1716992246- Start Date: - 29/05/2024- Contact: - Niall Wharton- Specialism: - AI & Machine LearningMachine LearningDataData Science**SENIOR DATA...

  • Senior Data Scientist

    2 meses atrás

    Lisboa, Portugal Xcede Tempo inteiro

    **Senior Data Scientist**: - Location: - Lisbon- Salary: - €50000 - €70000 per annum + benefits- Job Type: - Permanent- Date Posted: - 11 minutes ago- Expiry Date: - 28/05/2024- Job Ref: - BBBH110084_1714325877- Start Date: - 28/04/2024- Contact: - Niall Wharton- Specialism: - DataData ScienceAI & Machine LearningMachine Learning**SENIOR DATA...

  • Senior Data Scientist

    2 meses atrás

    Lisboa, Portugal Humana Portugal Tempo inteiro

    SENIOR DATA SCIENTIST Xcede are delighted to be working with one of the world's largest gaming companies on the scale-up of their pre-existing Data Science & Machine Learning Division. The organisation have an enviable wealth of digital / B2C data available to them given the scale of their userbase. The company would like to capitalise further on this, hence...

  • Senior Data Scientist

    2 meses atrás

    Lisboa, Portugal Humana Portugal Tempo inteiro

    SENIOR DATA SCIENTISTXcede are delighted to be working with one of the world's largest gaming companies on the scale-up of their pre-existing Data Science & Machine Learning Division. The organisation have an enviable wealth of digital / B2C data available to them given the scale of their userbase. The company would like to capitalise further on this, hence...

  • Senior Data Scientist

    4 semanas atrás

    Lisboa, Portugal Xcede Recruitment Solutions Tempo inteiro

    SENIOR DATA SCIENTIST Xcede are delighted to be working with one of the world's largest gaming companies on the scale-up of their pre-existing Data Science & Machine Learning Division. The organisation have an enviable wealth of digital / B2C data available to them given the scale of their userbase. The company would like to capitalise further on this, hence...

  • Senior Data Scientist

    2 semanas atrás

    Lisboa, Portugal Xcede Recruitment Solutions Tempo inteiro

    SENIOR DATA SCIENTIST Xcede are delighted to be working with one of the world's largest gaming companies on the scale-up of their pre-existing Data Science & Machine Learning Division. The organisation have an enviable wealth of digital / B2C data available to them given the scale of their userbase. The company would like to capitalise further on this, hence...

  • Senior Data Scientist

    4 semanas atrás

    Lisboa, Portugal Xcede Recruitment Solutions Tempo inteiro

    SENIOR DATA SCIENTISTXcede are delighted to be working with one of the world's largest gaming companies on the scale-up of their pre-existing Data Science & Machine Learning Division. The organisation have an enviable wealth of digital / B2C data available to them given the scale of their userbase. The company would like to capitalise further on this, hence...

  • Senior Data Scientist

    2 semanas atrás

    Lisboa, Portugal Xcede Recruitment Solutions Tempo inteiro

    SENIOR DATA SCIENTISTXcede are delighted to be working with one of the world's largest gaming companies on the scale-up of their pre-existing Data Science & Machine Learning Division. The organisation have an enviable wealth of digital / B2C data available to them given the scale of their userbase. The company would like to capitalise further on this, hence...

  • Analytical Scientist

    3 semanas atrás

    Lisboa, Portugal Hovione Tempo inteiro

    We are hiring an organized Analytical Scientist to join our growing team at Hovione in Lisboa. Growing your career as a Full Time Analytical Scientist is a fantastic opportunity to develop excellent skills. If you are strong in critical thinking, leadership and have the right mindset for the job, then apply for the position of Analytical Scientist at Hovione...

  • Analytical Scientist

    2 semanas atrás

    Lisboa, Portugal Hovione Tempo inteiro

    We are hiring an organized Analytical Scientist to join our growing team at Hovione in Lisboa. Growing your career as a Full Time Analytical Scientist is a fantastic opportunity to develop excellent skills. If you are strong in critical thinking, leadership and have the right mindset for the job, then apply for the position of Analytical Scientist at Hovione...

  • Regulatory Cmc Operations Manager

    2 meses atrás

    Lisboa, Portugal NonStop Consulting Tempo inteiro

    I am actively seeking a Regulatory CMC Operations Manager for a medium-sized pharmaceutical company who is rapidly growing. This strategic position is ideal for someone who thrives in a hands-on environment, and loves to challenge themselves, while growing with the company to develop their career even further. In this hands-on position you will be working...

  • Senior Scientist

    Há 6 dias

    Lisboa, Portugal Hovione Tempo inteiro

    .Senior Scientist - Oral Drug Product Development Lisboa Senior Scientist - Oral Drug Product DevelopmentLisboa Lisbon, Lisbon, Portugal Join a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities,...