28 June, 2022
AstraZeneca is Hiring for Regulatory Affairs Manager I
JOB TITLE : Regulatory Affairs Manager I
CAREER LEVEL: D
Lead the way for a new breed of solutions-oriented Regulators
Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development
Be part of the team where you are empowered to follow the science
Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals.
About the role
The Regulatory Affairs Manager will provide market specific regulatory affairs support resulted because of in-licensing or out-licencing activities in post deal space.
- Deliver and maintain competitive licences in specified markets on behalf of EU Marketing Companies (affiliates) including driving regulatory strategy.
- Ensuring regulatory compliance for defined product and project responsibilities, including project leadership.
- Timely delivery of approvals and maintenance of high regulatory compliance standards for specified markets achieved through provision of local regulatory expertise.
- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small molecules across all specified markets.
- Use and share standard methodologies, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
- Full compliance with Good Regulatory Practices (GRP) requirements in line with the local Quality Management System (QMS) Standard Operating Procedures (SOP) and all other policies and Standards.
- Participate in the development of regulatory affairs ‘ways of working’ in unique scenarios resulted because of business development activities, involving multiple customers like licencing partner, global regulatory affairs, business development, marketing company regulatory teams etc.
Minimum Requirements –Education and Experience
- Relevant University Degree in Science or related subject area
- Around 6-11 years regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets
- General knowledge of drug development
- Thorough knowledge of the regulatory product maintenance process
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
- Regulatory affairs experience across a broad range of markets
- Managed regulatory deliverables at the project level
- Experience of working with people from locations outside of India, especially Europe and/or USA
Skills and Capabilities
- Excellent English written and verbal communication skills
- Cultural awareness
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Proficiency with common project management (e.g., MS Project) and document management tools
- Ability to work independently and as part of a team
- Influencing and partner management skills
- Ability to analyze problems and recommend actions
- Continuous Improvement and knowledge sharing focused
Internal and External Contacts/Customers
- Global Regulatory Leads (GRLs)
- Regulatory Regional Leads (eg, US, EU, International RADs)
- Lead RPM
- Other R & D skill groups, eg, Global Regulatory Operations, Global Labelling Group, Operations Regulatory, Patient Safety
- Operations/Manufacturing organisation (CMC post approval)
- Marketing Companies/Local affiliates
- Health Authorities
- External collaboration partners