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 worlds most serious diseases. But were more than one of the worlds 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 companys 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 clinical trials/Phase IV/PMS studies including SEC preparation

Manages regulatory compliance during study conduct including renewal/amendments and till study closure with minimum supervision from manager

Maintain complete documentation records and all trackers are timely maintained.

Job Location : Mumbai

Experience : 3-6 years

Education Qualifications Skills and Experience

Essential

3-6yrs relevant Experience in India Regulatory function knowledge of dossier compilation and review.

Should be conversant with Indian regulations.

Desirable

Knowledge of dossier compilation.

Conversant with Indian regulations related to new drugs and clinical trials.

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were on an exciting journey to pioneer the future of healthcare.

You can find alternative messaging to use in the Global Talent Attraction Story messaging section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates!

So whats next

• Are you already imagining yourself joining our team Good because we cant wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table Brilliant! We have one seat available and we hope its yours.

Where can I find out more

Our Social Media Follow AstraZeneca on LinkedIn AstraZeneca on Facebook AstraZeneca on Instagram you have site country or departmental social media then feel free to switch any of the above links.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.