Job title: Regulatory Affairs Manager I
Company: AstraZeneca
Job description: 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 astrazeneca
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development
About the team
We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.
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.
Typical Accountabilities
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
Preferred Experience
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
WHY JOIN US ?
We believe there’s always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.
Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to contribute throughout
SO, WHAT’S NEXT?
Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
Date Posted 24-Jun-2022
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Expected salary:
Location: Bangalore, Karnataka
Job date: Sun, 26 Jun 2022 03:11:52 GMT
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