Regulatory Operations Expert

• *Job Overview:**

Scientific Writer with strong expertise in material science, analytical chemistry, and chemical principles (organic and inorganic) as applied to pharmaceutical formulation, manufacturing, and product lifecycle management.

This role serves as a scientific authority for translating material, analytical, and process knowledge into robust, lifecycle ready CMC documentation. The position is a key enabler of knowledge capture, scientific consistency, and regulatory defensibility across technology transfer, PPQ, and commercial manufacturing.

You work at the interface of science, manufacturing, quality, and regulatory, ensuring that how we understand materials and processes is clearly articulated, justified, and sustained throughout the product lifecycle

• *Summary of Responsibilities:**

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally.

• *Scientific Leadership \& CMC Knowledge Translation**

• Act as a **scientific owner** for the development of **high‑quality CMC documentation** related to:

+ Pharmaceutical raw materials and excipients

+ Process aids and contact materials (incl. leachables \& extractables)

+ Material changes, supplier changes, and lifecycle optimization activities

• Translate **complex analytical, chemical, and manufacturing data** into:

+ Scientifically rigorous justifications

+ Risk assessments and material qualification reports

+ CMC sections supporting variations, supplements, and regulatory responses

• Ensure scientific content is **aligned with Quality‑by‑Design principles** and clearly supports:

+ Control strategies

+ Defined design space and material attribute justifications

+ Lifecycle change management

• *Analytical Chemistry \& Chemical Understanding**

• Integrate and critically interpret **analytical chemistry data** , including:

+ Physicochemical characterization

+ Impurity and degradation profiles

+ Elemental and inorganic contaminants

+ Comparability and trend analyses

* Apply **organic and inorganic chemistry principles** to

+ Assess material composition, chemical reactivity, and degradation pathways

+ Evaluate compatibility with formulations, processes, and packaging systems

+ Support scientifically sound impurity and risk justifications

• Identify analytical **data gaps** and define scientifically appropriate strategies to close them, in collaboration with analytical development and external laboratories.

• *Manufacturing Processes, Unit Operations \& MSAT Lifecycle Support**

• Provide scientific assessments on the **impact of material attributes on pharmaceutical manufacturing processes and unit operations** , including:

+ Blending, granulation, drying, compression, coating

+ Mixing, filtration, emulsification, sterilization (as applicable)

• Support **technology transfer, PPQ, and commercial manufacturing** by:

+ Documenting material‑process interactions

+ Supporting root cause investigations and comparability assessments

+ Providing scientific rationales for process or material changes

• Ensure scientific conclusions reflect **manufacturing reality** , robustness, and process capability, not only laboratory observations.

• *Lifecycle Management, Compliance \& Regulatory Alignment**

• Ensure documentation is fully **aligned with global regulatory and compliance expectations** , including:

+ ICH Q8–Q12 principles

+ Pharmacopeial requirements

+ GMP expectations for materials, suppliers, and change management

• Support **regulatory submissions, variations, and health authority interactions** by:

+ Providing clear, defensible scientific rationales

+ Ensuring consistency between analytical data, process understanding, and CMC narratives

• Maintain strong **traceability** between experimental data, conclusions, and regulatory positions throughout the product lifecycle.

• *Cross‑Functional Scientific Collaboration**

• Act as a **scientific interface** between MSAT, Analytical Development, Formulation, Manufacturing, Quality, and Regulatory Affairs.
• Engage with **external suppliers, contract laboratories, and technical experts** to:

+ Clarify chemistry‑ and material‑related questions

+ Challenge data quality where needed

+ Ensure completeness and scientific credibility of external information

• Contribute actively to **knowledge management** within MSAT by ensuring scientific learnings are captured in a reusable, lifecycle‑oriented manner.

• *Qualifications (Minimum Required):**

• Bachelor’s in Pharmacy or related science degree (or equivalent); **OR** Advanced Degree (e.g., PhD or Masters) as applicable. “ *Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.”* **OR**
• Advanced degree (MSc or PhD) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences
• Innovation and Proactive, taking ownership, Precise, Goal oriented.
• Leadership, problem solving, interpersonal skills.
• Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
• Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH\-GCP guidelines desirable Years of experience in the job discipline.
• Good organizational and time management ability
• Good analytical capabilities and Customer focus
• Good review skills and concern for quality
• Capabilities to face internal and external Audit situation
• Excellent command of written and spoken English and/or other languages as applicable

• *Experience (Minimum Required):**

• At least 7\-9 years of experience in the job discipline (e.g. Regulatory Affairs/Quality Assurance/Analytical Science / Packaging, polymer and/or Pharmaceutics / material management, Advanced degree (MSc or PhD) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences and overall drug development and manufacturing process
• Minimum 1\+ year of experience in project management is desirable.
• Strong, hands on scientific understanding of:
• Analytical chemistry and material characterization
• Organic and inorganic chemistry relevant to pharmaceutical materials
• Pharmaceutical manufacturing processes and unit operations
• Demonstrated experience in CMC relevant scientific documentation, including:
• Material qualification and risk assessments
• Comparability and lifecycle justifications
• Regulatory facing scientific narratives
• Ability to independently analyze complex datasets, draw defensible conclusions, and clearly articulate scientific rationale.
• Familiar with pharmaceutical compliance, including GMP expectations for materials, suppliers, and lifecycle change control.

• *Preferred Qualifications Include:**

• Bachelor’s in pharmacy or related science degree (or equivalent); **OR** Advanced Degree (e.g., PhD or Masters) with 7\-9 years of relevant experience. “ *Fortrea may consider relevant and equivalent experience in lieu of educational requirements* .” **OR**
• Advanced degree (MSc or PhD) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences
• Knowledge of Management Information System (MIS) and electronic data management system (eg: Regulatory Information Management, etc.) system will be preferred
• Diploma or Certification in Regulatory Affairs will be preferred
• Innovation and Proactive, taking ownership, Precise, Goal oriented.
• Leadership, problem solving, interpersonal skills.
• Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
• Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH\-GCP guidelines desirable Years of experience in the job discipline.
• Good organizational and time management ability
• Good analytical capabilities and Customer focus
• Good review skills and concern for quality
• Scientist mindset with a strong sense of ownership and accountability for scientific quality.
• Analytical, structured, and rigorous in data interpretation and verification.
• Proactive and confident in engaging senior scientific, manufacturing, and regulatory stakeholders.
• Strong communicator who can convert complex science into globally aligned, regulator ready CMC knowledge.

• *Physical Demands / Work Environment:**

• *Office/Home\-Based:**

• *Work Environment:**

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
• Available for regional or global travel 5\-10% of the time including overnight stays as necessary consistent with project needs and office location.

• *Physical Requirements:**

• Frequently stationery for 6\-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in\-house and off\-the\-shelf.
• Light to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum lift of 15\-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

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