Regulatory Affairs Director
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Södertälje • 🇸🇪 Sweden
Visit company websiteJob Level
Lead
About the role
- Provide CMC RA expertise across the business functions
- May lead key business improvement initiatives
- May sit on external industry groups
- Provide strategic CMC RA expertise and direction for CMC submissions across the lifecycle of a product
- Provide novel strategies and support new approaches from the technical functions
- Where necessary lead CMC related interactions with Health Authorities
- Accountable for the provision of regulatory strategic guidance in support of Operational initiatives, for example, manufacturing capacity expansion
- Lead policy setting and strategy development in the CMC RA environment within or external to AstraZeneca
- Share knowledge, leading/contributing to Communities of Practice across the groups or within a business unit
- Accountable for managing high level risk by making complex judgments, developing innovative solutions including proactive risk management and mitigation
- Provide AZ technical functions clear, concise guidance on current CMC regulatory requirements to support business tactical and strategic planning
- Provide expert recommendations and decisions on regulatory issues relating to CMC
- Support the development and implementation of novel strategies in CMC regulatory affairs to enhance efficiency and flexibility in the CMC dossier
- Contribute to cross therapeutic non-drug projects and support business processes to deliver accelerated submissions, support launch activities / ensure management of regulatory information and ensure regulatory compliance on behalf of AZ
Requirements
- Bachelors degree in Science, Regulatory Sciences or Pharmacy
- Breadth of knowledge of manufacturing, project, technical and regulatory project management
- Strong understanding of regulatory affairs globally
- Direct experience with CMC Regulatory submissions for chemically synthesised molecules
- Experience of clinical development of innovative pharmaceutical APIs and Drug Products
- Experience within Synthetic / Small molecules environment
- Regulatory experience in at least one of the following areas: inhalation, modelling, advanced manufacturing, or complex APIs such as oligonucleotides, conjugates, PROTACs, or peptides
- Stakeholder & Project management skills
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CMC regulatory submissionsregulatory strategic guidanceproject managementtechnical project managementregulatory complianceclinical developmentmanufacturing capacity expansionnovel strategies in CMCrisk managementregulatory affairs
Soft skills
leadershipstakeholder managementcommunicationstrategic planningproblem-solvinginnovationcollaborationknowledge sharingdecision makingjudgment
Certifications
Bachelors degree in ScienceBachelors degree in Regulatory SciencesBachelors degree in Pharmacy