Regulatory Affairs Consultant - MAAs Global Acceleration Initiative

We are seeking experienced Regulatory Affairs professionals to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets. This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in Global Country Initiative (GCI), emerging markets, and non-EU markets. Our global regulatory teams are well supported to prioritise our major markets filings and are targeting high quality simultaneous filings with Stringent Regulatory Authorities (SRAs)as well as rest of world markets. Our ambition is to accelerate the time for submission, approvals and accessing markets, and this role's mission will be to help realise this ambition.,

• Develop and implement global regulatory strategies for simultaneous marketing authorisation submissions
• Identify risks and mitigations to protect business interests and maintain timelines
• Lead detailed preparation of regulatory plans for individual country filings
• Lead global filing teams in generating country-specific datasets and updating core documentation
• Lead adaptation of core dossier contents for country submissions
• Coordinate filing teams for RTQ generation, provide strategic guidance to the global filing teams to address the regulators question and guide the team to prepare high quality responses.
• Set up global filing team meetings, draft responses, coordinate reviews and approvals.
• Suggest and coordinate innovative regulatory procedures to increase acceleration opportunities
• Work closely with the local and regional regulatory leads on all aspects of marketing review and approvals.
• Manage routine MA maintenance activities as required
  
  University degree in a life science industry
• 8-15 years of relevant regulatory affairs experience
• Extensive experience in preparing global filing plans for markets worldwide, and awareness of regulatory frameworks in all major markets globally
• Strong leadership skills and motivated, to support senior filing teams through marketing applications, overarching CMC, Clinical and Nonclinical.
• Familiarity with CPPs and timing for filings in various markets
• Proficiency in Veeva Vault and other regulatory systems
• Excellent communication and organizational skills
• Experience working within a regulatory matrix team in the pharmaceutical industry
• Fluent in English, written and spoken
  
  When you join us, you're joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there's no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change - forever. And together, we'll do it With Heart ., Parexel is among the world's largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.