Regulatory Affairs Executive

Job Title: Regulatory Senior Executive

Location: Ware or London

Contract: 12 Months / Hybrid

Hours: 37.5 hours

Rates: £448.80 p/d

Job Description

SRG seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join a Small Molecules Development Projects CMC Regulatory Affairs Group for a leading pharmaceutical company. As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Executive, you will be responsible for managing global acceleration of CMC regulatory marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, responding readily to changing events and priorities.

Duties and Responsibilities

• Driving the CMC strategy for global and regional acceleration submissions to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards and taking account of evolving regulatory requirements.
• Ensuring all appropriate CMC regulatory submissions are in place, to enable rapid launch and continuity of market supply.
• Taking accountability for submission content and ensuring information submitted in marketing applications/lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
• Understanding and advising on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of pharmaceutical products.
• Identifying risks to the business associated with submission data and information packages and communicating well defined risk mitigation strategies.
• Delivering CMC regulatory strategy to support major inspections or quality incidents.
• Managing project activities for multiple complex projects and teams simultaneously.
• Objective evaluation of data and regulatory environment to provide strategic direction, supporting conclusions with data/precedent/guidance, and assertively presenting opposing view/position when necessary.
• Evaluating CMC Regulatory processes, policies and systems, formulating novel approaches and influencing people to enhance the efficiency and quality of departmental work.

Experience and Qualifications

• Bachelor's degree.
• Significant regulatory affairs experience.
• Experience of drug development and manufacturing and supply processes.
• Experience of negotiating with regulatory agencies, industry bodies, and internal colleagues in a variety of settings.
• Experience of filing activities (such as MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/pre-Phase 3 or other regulatory interactions in early development).

Preferred Qualifications and Skills:

If you have the following characteristics, it would be a plus:

• Master of science degree or PhD.
• Development experience ideally including previous roles within pharmaceutical and/or vaccines product development.
• Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of managing complex regulatory strategies. Typically has significant experience managing agency interactions.
• Highly developed interpersonal, presentation and written communication skills with experience of communicating with senior stakeholders.
• Able to establish internal networks, whilst understanding departmental constraints/pressure within a highly complex organization.