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AstraZeneca hiring Regulatory Affairs Manager
Regulatory Affairs Manager
📍India – Bangalore
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.
Position purpose
For assigned products: Developing India-specific Artwork, Support Regulatory dossier preparation and Submissions like New drug applications, Site registration, clinical trial and Import licence. Managing Registration samples right from dispatch of samples till the report. Licence Life cycle management. Adequate representation in SEC
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/ 6-10yrs Experience in India Regulatory function, knowledge of dossier compilation. He/ she should be 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 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 breach 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, 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
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 information for its impact on AstraZeneca proposed pipelines
Provide scenario with options and a risk – benefit analysis for AstraZeneca going forward
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