Regulatory Affairs Manager

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

Provide Leadership and direction within project teams

• Strive to ensure high levels of performance and achievements.
• Take decision and accountability for actions.
• Build commitment within the team.
• Enhance positive attitudes and mindset. Demonstrate confidence and conviction.
• Challenge status quo for continuous improvement.
• Help build an open and trusting atmosphere.

Assist in Issue Management

• Provide detailed information of 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 information for its impact on AstraZeneca proposed pipelines
• Provide scenario with options and a risk – benefit analysis for AstraZeneca going forward

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.

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