Associate Principal Scientist, Regulatory Affairs-CMC in Burnley

Reporting to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre‑approval Pharmaceutical CMC, the role is responsible for developing and implementing CMC regulatory strategies for the company’s pharmaceutical pipeline products in accordance with global regulations and guidance, and for the preparation and submission of CMC dossiers for all assigned development products.

Regulatory Responsibilities

• Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product development, including assessment of the probability of regulatory success with risk mitigation measures.
• Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identify potential risks.
• Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.
• Provide regulatory leadership in product in‑license/due diligence review and product transition to the Post‑Approval Pharm CMC team.
• Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
• Identify, communicate and escalate potential regulatory issues to GRACS CMC management as needed.
• Demonstrate an understanding of regulatory affairs and apply this understanding to benefit the company, ensuring the approval and market supply launch of our pharmaceutical products worldwide.
• Conduct all activities with an unwavering focus on compliance.

Education

• Bachelor’s degree in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry.

Required

• At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
• The candidate must be proficient in English; additional language skills are a plus.

Preferred

• Experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills, and demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Ability to develop innovative and imaginative approaches to problem solving and to flexibly respond to changing priorities or unexpected events.
• Strong collaboration skills, rapid disciplined decision making and critical thinking capabilities, and ability to work well under pressure.
• Excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with and influencing multi‑disciplinary teams.
• Proficient in critically reviewing detailed scientific information to assess whether technical arguments are presented clearly and conclusions are adequately supported by data.

Required Skills

• Adaptability
• Applied Engineering
• Biochemistry
• Biological Sciences
• Biologics License Application (BLA)
• Business Processes
• Chemical Engineering
• Cross‑Cultural Awareness
• Detail‑Oriented
• Electronic Common Technical Document (eCTD)
• Employee Training Programs
• Innovation
• International Regulatory Compliance
• Manufacturing
• Microbiology
• Molecular Microbiology
• Oral Communications
• Pharmaceutical Process Development
• Regulatory Affairs Compliance
• Regulatory Affairs Management
• Regulatory CMC
• Regulatory Strategy Development
• Regulatory Submissions
• Regulatory Writing

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.