Location: Bangalore, India
Job ID: R-210833
Functional Area: Regulatory Affairs
Application Deadline: 30th October 2024
Company Overview: AstraZeneca is dedicated to making a meaningful impact on global health. Our commitment extends beyond delivering innovative medicines; we actively contribute to the economy and community welfare. In 2009, we commissioned a report through Oxera, an independent economic consultancy, to highlight our significant investment in the UK economy, including job creation and wealth generation.
Job Description: As an Associate Regulatory Affairs Director I, you will play a vital role in shaping regulatory submission strategies. You will be responsible for identifying submission risks and opportunities, leading regulatory applications, and managing approval procedures. Your expertise will be essential in providing guidance on procedural and documentation requirements across various teams, ensuring alignment with business objectives. Additionally, you will oversee the maintenance of global labeling documents for designated products and manage regulatory as well as basic clinical and non-clinical publishing deliverables.
Key Responsibilities:
- Develop and execute regulatory submission strategies.
- Lead regulatory applications and manage processes through approval.
- Provide regulatory expertise to cross-functional teams.
- Maintain global labeling documents for assigned products.
- Plan and manage regulatory and publishing deliverables.
Candidate Profile:
- Education: Relevant University Degree in Science or related discipline.
- Experience: Minimum 9 years of regulatory experience within the biopharmaceutical industry.
- Knowledge:
- Strong understanding of drug development and regulatory product maintenance processes.
- Familiarity with complex regulatory deliverables across projects/products.
- Skills:
- Proven project management and leadership capabilities.
- Excellent written and verbal communication skills in English.
- Strong scientific background to facilitate discussions on regulatory issues.
- Proficiency in project management and document management tools (e.g., MS Project).
- Ability to work both independently and collaboratively within a team.
- Strong influencing and stakeholder management skills.
- Analytical mindset for problem-solving and action recommendations.
- Commitment to continuous improvement and knowledge sharing.
Why Join Us? At AstraZeneca, you’ll be part of a collaborative team that values your contributions and fosters professional growth. Join us in our mission to innovate and improve health outcomes globally.
How to Apply: Interested candidates should submit their applications by 30th October 2024.
AstraZeneca is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.