Job Description

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.