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 title Sr Manager Regulatory Affairs

Position purpose

a)Liaison with regulatory bodies such as CDSCO, IPC, NIB, MoH, ICMR etc for required regulatory approvals

b)Lead Regulatory strategy and implementation for assigned TA and oversight of execution of strategy, timely submission, query responses, SEC meetings

Internal customers

Regulatory Affairs (RA) team in India and International ., Cross functional teams for assigned TAs- business/ medical/ supply chain/ QA

External customers

CDSCO Office, NIB, IPC, CDL,ICMR. MoH and other Health Authorities/ Government Agencies as needed, Industry associations

Minimum requirements

Qualification: M.Pharm/ B.Pharm/ M.Sc/ BSc with 12-15yrs Experience in India Regulatory function, relationship with regulatory officials. He/ she should be conversant with Indian regulations.

Key Result Areas/ outputs

CDSCO HQ (New Drug, SNDA, FDC, Import, Biological, GCT Division, CDAC)

• Following up for approvals for new drugs, SNDs, biologics, FDC, GCTs, package insert, Post approval Changes, Import
• Coordinating with CDSCO HQ for Queries if any and seek clarification for resolution of query responses
• Follow-up with respective CDSCO division for timely SEC inclusion of applications
• Regulatory intelligence for competitor products

IPC Lab/ NIB Noida Ghaziabad

• Ensure submission of test samples to IPC for non-biologicals and NIB for biologicals and follow up for Testing report of submitted samples for regulatory approval
• Follow-up for inclusion of monograph in I.P. as per request

ICMR To f-u if needed for global trials, drug development projects, Gene Therapy products if any

DGHS- Organise meeting with DGHS for Technical committee proposals if any

Organising meetings

• Organising meetings of Director RA along with stakeholders if needed, with CDSCO officials, DGHS, IPC, NIB, ICMR as requested
• Relationship building with new officials as needed

Regulatory Intelligence:

• Vigil on regulatory updates of generics/ competitor and provide intelligence information to RA team as requested

Newer regulations/ guidance

• Discuss with regulatory officials for implementation guidance on newer regulations as requested

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, anti-bribery and anti-corruptions policies

Ensure that company confidentiality is maintained (i.e. intellectual property, product information, strategic information)

Disclose potential breach of codes or conducts.

Key Result Areas/outputs Activities

Ensure timely approvals for new drugs/ SNDs/ pack insert/ phase IV

Follow-up with regulatory officials to ensure timely review, SEC inclusion and approval as per business priorities.

For assigned TA if any, ensure regulatory strategy making, timely submission, SEC preparedness and approval along with guidance to concerned RA team member.

Global Clinical trial applications

• Follow-up for timely review/ SEC inclusion, approvals of GCT, amendments, test-lic.
• For assigned TA if any, ensure timely submission/ SEC preparedness/ approval of GCT.

Collaboration and people management

• Impactful collaboration across cross functional teams- RA team in H.O., supply chain, business/ medical as needed
• Guidance to junior RA associates/ contract associates
• Import registration
• Ensure timely renewal of import registration licenses/ production transfers/ post approval changes if any.

Regulatory compliance

• Ensure regulatory compliance for life cycle maintenance products and clinical trials as per norms including post approval commitments.

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

• Monitor and understand the impact of external changes in the regulatory and political environment with impact assessment and communicate to key stakeholders.
• Support RA leadership for regulatory policy shaping
• Actively participate in Industry association meetings as assigned.

Regulatory competitive Intelligence and Analysis

• Keep vigil on generics/ competitors and share regulatory intelligence with relevant stakeholders as requested

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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Where can I find out more?

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