AstraZeneca job vacancy for Regulatory Affairs Manager-apply now

AstraZeneca Bengaluru East, Karnataka, India

About the job

About Astrazeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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.

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
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
Project 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 Issue Management

Provide detailed information on the regulatory status of affected products
Undertake assigned follow-up action where necessary

Maintain the awareness of, and shape the regulatory environment relevant to the assigned products portfolio

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