Head of Regulatory Affairs

Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Fraser Dove InternationalAssociate Director / Life Sciences / Executive Search / Biologics / Biotech / Pharmaceuticals / VC / PE / Quality & RegulatoryHead of Regulatory AffairsAre you a senior regulatory affairs (RA) leader with a passion for bringing complex biologics to patients worldwide?Do you have a recent track record leading successful biologics licence application (BLA) approvals in the United States (US) and European Union (EU)?Are you ready to relocate to Asia to shape and lead global regulatory strategy for a growing biologics portfolio?Fraser Dove International is partnering exclusively with a innovative biologics organisation. Operating globally from a key hub in East Asia, they are committed to improving patient lives through high quality, life changing injectable therapies.Our client is seeking a seasoned leader to drive global regulatory strategy and submissions for their biologics portfolio.Discover more about our Head of Regulatory Affairs opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.Your objectives:Deliver successful BLA submissions and approvals in the US and EU in line with agreed timelines and quality standards.Ensure sustained compliance with global regulatory and good manufacturing practice (GMP) requirements across development, manufacturing and post marketing activities.Build and maintain strong, trusted relationships with key health authorities and internal stakeholders to support the company’s growth and product pipeline.What you will do:Lead the planning, preparation and delivery of global regulatory submissions to secure initial and lifecycle approvals.Act as a key contact with health authorities including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), National Medical Products Administration (NMPA), Health Canada and others.Provide clear regulatory advice and cross functional support to quality, production, clinical and other teams to ensure alignment and compliance.Author, review and approve high quality CMC and clinical documents for BLAs and other regulatory applications.Lead and support regulatory inspections and audits, ensuring inspection readiness and effective follow up on any findings.Oversee regulatory aspects of product complaints and compliance issues in close collaboration with the Quality team.Monitor regulatory and industry trends in biologics and advise leadership on potential impact and risk mitigation.What you will bring:Significant leadership experience in RA roles within the biologics sector, ideally at senior manager level or equivalent.Proven track record leading successful BLA submissions in the US and EU within the last five years.Deep understanding of GMP and global regulatory compliance principles, with experience supporting regulatory inspections.Strong interpersonal and cross cultural skills, with experience working in a global, multicultural organisation.Ability to collaborate effectively with onsite, hybrid and remote teams, and to represent the organisation confidently to regulators and partners.Bachelor’s degree in a life science or related discipline; an advanced degree is preferred.Ability and willingness to relocate to South Korea and to travel internationally as required.What you will get:These are the perks and benefits that will complement your generous base salary.Got what it takes?To apply for the Head of Regulatory Affairs, click the ‘Apply’ button below or contact the Executive Search Consultant – Peter Vedde – on +44 (0) Please Note:This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job related instructions and to perform any other job related duties requested by any person authorised to give instructions or assignments.If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website: levelExecutiveEmployment typeFull-timeJob functionQuality Assurance, Manufacturing, and Health Care ProviderIndustriesBiotechnology Research, Pharmaceutical Manufacturing, and Hospitals and Health Care#J-18808-Ljbffr