Regulatory Affairs Manager
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 license. Managing Registration samples right from dispatch of samples till the report. License 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.
Job Description
- 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 awareness of, and shape the regulatory environment relevant to the assigned products portfolio.
- Competitive Intelligence and analysis.
- 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.
- 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.
- 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.
- 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.
- Provide detailed information on the regulatory status of affected products.
- Undertake assigned follow-up action where necessary.
- 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.
- Monitor the global pipelines of competing pharmaceutical companies.
- Analyze gathered information for its impact on AstraZeneca proposed pipelines.
- Provide scenario with options and a risk – benefit analysis for AstraZeneca going forward.
Candidate Profile
M.Pharm/B.Pharm/ 6-10yrs Experience in India Regulatory function, knowledge of dossier compilation. He/ she should be conversant with Indian regulations.
Additional Information
