Why choose AstraZeneca India?
Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare.
The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports.
Who do we look for?
Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.
Success Profile
Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.
Tech innovators
Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives.
Ownership takers
If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it.
Challenge seekers
Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks.
Proactive collaborators
Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best.
Responsibilities
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Lead Regulatory Affairs & GRP Lead
Reports to Director - Regulatory Affairs
Position purpose
For assigned products: Regulatory Acceleration process Plan to gain rapid and high-quality approvals and ensure a high standard of regulatory compliances, SEC/TC/APEX Preparation, in order to achieve the company’s business objectives. Developing India-specific Artwork, Support to Regulatory dossier preparation and submissions like New drug applications, Site registration, Clinical trials and Import licence. Managing Registration samples right from dispatch of samples till the report. As part of a New drug application, ADC sample testing. Also follow up for reports, Licence Life cycle management. Revision of existing licenses, and artworks, where gaps are identified, for compliance with existing licenses. Facilitates a second review of external submissions. Handling of promo mats
Internal customers Marketing, Sales, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites and QA, Regional Office
External customers CDSCO Office, NIB, IPC, CDTL, CDL, NCB, & DCK and other Local Health Authorities and other Government Agencies, Manufacturers, Local Trade Associations, Legal Professionals
Minimum requirements Qualification: M.Pharm/B.Pharm/ 10-14 years’ Experience in India Regulatory function, knowledge of dossier compilation. He/ she should be well conversant with Indian regulations.
Key Result Areas/ outputs · Adherence to AZ and industry codes of conduct, ethics and good regulatory practices · Ensure that all licensing for assigned products is complete in accordance with relevant norms · Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate the rapid launch · Provide Leadership and direction within project teams · Assist in Issue Management · Maintain the awareness of, and shape the regulatory environment relevant to the assigned products portfolio · Competitive Intelligence and analysis
Key Result Areas/outputs Activities
Adherence to AZ and industry codes of conduct, ethics and good regulatory practices · Align with the values and vision of AZ · Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance and Audit requirement · Ensure that company confidentiality is maintained (i.e. intellectual property, product information and strategic information) · Disclose potential breaches of codes or conducts
Key Result Areas/outputs Activities
- . Ensure that all licensing for assigned products is complete in accordance with relevant norms
- Monitor status of product licenses
- Manage changes in product licenses and coordinate with other changes, planned and in progress
- Maintain complete documentation records
- Communicate changes to licenses status promptly
- Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch
- Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy
- Ensure that local regulatory strategies are consistent with global product strategies and local priorities
- Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time
- Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch
- Provide Leadership and direction within project teams
- Strive to ensure high levels of performance and achievements.
- Take decisions and accountability for actions.
- Build commitment within the team.
- Enhance positive attitudes and mindset.
- Demonstrate confidence and conviction.
- Challenge the status quo for continuous improvement.
- Help build an open and trusting atmosphere
- Assist in Issues.
- Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions · Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products · Communicate the impact of changes to key stakeholders. · Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes · Develop excellent relationships and partnerships with Regulatory Authorities
Competitive Intelligence and Analysis · Monitor the global pipelines of competing pharmaceutical companies · Analyse gathered the information for its impact on AstraZeneca’s proposed pipelines · Provide a scenario with options and a risk–benefit analysis for AstraZeneca going forward
Key result areas/outputs Activities
GRP Quality Lead · Ensuring the GxP area(s) under their responsibility are run in accordance with external regulations. · Ensuring appropriate levels of resources to complete GRP activities · Providing/coordinating training and coaching in the related GxP area for the MC QMS · Identifying/agreeing on areas of compliance risk and follow-up of any issues · Ensuring GxP self-assessments in the corresponding GxP area · Monitoring KPIs in the related GxP area and proposing remedial and improvement actions · Establishing improvement priorities · Monitoring internal/external factors such as emerging regulations or shifts in regulatory enforcement · Identifying trends and communicating identified risks · Establishing and maintaining business continuity plans in the corresponding GxP are
Why 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, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
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.
Reasons to Join
Thomas Mathisen
There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.
Christine Recchio
Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.
Stephanie Ling
There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.
What we offer
We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you.
Lifelong learning
Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still.
Autonomy and reward
Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package.
Health and wellbeing
An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority.
Inclusion and diversity
Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.
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