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Sr. Scientist, Regulatory Affairs - Chemistry, Manufacturing & Controls (CMC)

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Organon

2mo ago

  • Job
    Full-time
    Junior & Mid Level
  • Science
    Research & Development

AI generated summary

  • You must have a relevant degree, CMC experience, strong communication skills, regulatory expertise, project management abilities, and a knack for innovative problem-solving in a dynamic environment.
  • You will assess CMC changes, develop and review regulatory documentation, liaise with partners for compliance, manage risks, and ensure timely submission compliance throughout the product lifecycle.

Requirements

  • Bachelor’s degree, in a science, engineering, or a related scientific field. Fields of study include Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmacy, Microbiology, Virology, or Molecular Biology with at least four years of overall relevant work experience OR
  • Advanced degree (MS, MBA, Ph.D., PharmD) in a science, engineering, or related scientific field. Fields of study include Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmacy, Microbiology, Virology, or Molecular Biology with at least two years of overall relevant work experience.
  • Minimum of two (2) years of relevant CMC experience, including biological/pharmaceutical research; manufacturing, testing or a related field.
  • The candidate must be proficient in English; additional language skills are a plus.
  • Evaluation of Subject Matter Expert (SME) technical documentation for completeness and sufficient details in order to make accurate regulatory assessments through utilization of current global regulatory guidances.
  • 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.
  • Familiar with regulatory guidelines for product post-approval change management and data requirement.
  • 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 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.
  • Managing multiple projects to ensure on-time deliverables and timely submissions to ensure product supply continuity.
  • Direct experience in Regulatory CMC and/or authoring of regulatory documentation.
  • Device and/or combination product regulatory experience.

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 global regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements and responses to health authority questions per established business processes and systems.
  • Ensure product compliance through timely and accurate maintenance of CMC submissions in the systems.
  • Liaise 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.
  • 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 our company's Regulatory CMC management, as needed.

FAQs

What is the primary responsibility of the Sr. Scientist in Regulatory Affairs - CMC?

The primary responsibility of the Sr. Scientist is to implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned products in accordance with global regulations and prepare and review information for regulatory CMC dossiers.

What level of education is required for this position?

A Bachelor’s degree in a science-related field is required with at least four years of relevant work experience, or an advanced degree (MS, MBA, Ph.D., PharmD) with at least two years of relevant work experience.

What specific experience is necessary for this role?

A minimum of two years of relevant CMC experience, including biological/pharmaceutical research or related fields, is required.

Are additional language skills beneficial for this position?

Yes, proficiency in English is required and additional language skills are a plus.

What technical skills are essential for a candidate applying for this role?

Candidates should have the ability to evaluate technical documentation, review scientific information for technical merits, and be familiar with regulatory guidelines for product post-approval change management.

What leadership skills are expected from the Sr. Scientist?

Effective leadership, communication, interpersonal, and negotiating skills, along with the ability to manage multiple projects and adapt to changing priorities are expected.

Is direct experience in Regulatory CMC preferred for this position?

Yes, direct experience in Regulatory CMC and/or authoring of regulatory documentation is preferred.

What is Organon's commitment regarding equal opportunity employment?

Organon is committed to creating an inclusive environment for all applicants and welcomes applications from candidates with diverse backgrounds.

What are the travel requirements for this position?

Travel requirements are approximately 10%, and employees must meet all applicable travel and credentialing requirements.

What work arrangements are available for this position?

Flexible work arrangements, including Flex Time, are available for employees.

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Organon

Here for her health

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Organon is a global healthcare company dedicated to improving the health and well-being of women throughout their lives. They focus on a broad portfolio that includes reproductive health, heart disease, dermatology, and more, with the aim of addressing health needs that are often underprioritised. Their ultimate mission is to help women live healthier and longer lives by providing innovative and impactful medical products and solutions. Organon's purpose is to create a better and healthier everyday life for women around the world, while contributing to advancements in global health care.