Assistant Manager - Regulatory Affairs

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.

Job Description/ Capsule

For assigned products: Regulatory strategy for NCE, Acceleration process Plan to gain rapid and high-quality approvals and ensure high standard of regulatory compliance, SEC Preparation, in order to achieve the company’s business objectives. Developing India specific Artwork, Support to Regulatory dossier preparation and Submission like New drug application, Site registration and Import licence. Managing Registration sample right from dispatch of samples till the report. As part of new drug application, ADC sample testing. Also, follow up for reports, License Life cycle management; Preparation & submission of PSURs.

Core Accountabilities

Key Result Areas/ outputs:

• Adherence to AZ and industry codes of conduct, ethics and good regulatory practices • Ensure that all licensing activities for assigned products are completed in full compliance with all applicable regulations and relevant standards.

• Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch

• Assist in Issue Management

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

• Competitive Intelligence and analysis.

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.

Ensure that all licensing activities for assigned products are completed in full compliance with all applicable regulations and relevant standards.

 Monitor status of product licenses

• Manage changes in product licenses and plan submission and approval of changes, planned and in progress

• Maintain complete documentation records

• Communicate changes to licenses status promptly.

Develop and implement 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

• Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch 2

• Strive to ensure high levels of performance and achievements.

Take decision and accountability for actions.

• 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 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.

Management of India PSUR submission

• Keep PSUR Calendar updated for India

• Prepare India specific PSURs based on the global PBRER

• Submit the PSURs to Health Authorities within timeline

• Responsible for responding to Health Authority Questions based on PSUR

Handles submission/review/query responses for global cl