196 Regulatory Affairs Specialists jobs in Bangalore

Job Summary:

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.

Responsible for:

• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio

• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products

• Collaboration with partners to develop and execute global regulatory activities

• DMF preparations, review of changes and routine updates to Global Regulatory Agencies

• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution

• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements

• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle

• Support development and execution of clinical/non-clinical strategies

• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration

• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans

• With minimal supervision, participate in development of risk management and contingency planning

• Ensure and lead regulatory compliance for biosimilar products

• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:

• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products

• Review and assess impact of regulatory decisions for competitive products

• Generate and communicate biosimilar intelligence Collaboration:

• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products

• Identify process needs to meet internal challenges

• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and

Skills

• Comprehensive understanding of Regulatory activities

• Regulatory experience with product filings

• Team skills, especially in working with internal and external partners

• Familiarity with project management requirements

• Ability to understand and communicate scientific CMC information

• Anticipate and prevent potential issues

• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission

Education

Doctorate degree OR Master's degree

Position Summary

The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in emerging markets. Key Activities required for this job are as below

• Develop and implement regulatory strategies for biosimilar products in LATAM.

• Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations in compliance with local requirements.

• Ensure adherence to regional regulatory reuqirements

• Evaluate and implement regulatory changes impacting product lifecycle.

• Manage post-approval activities including labeling updates, renewals, and change control assessments.

• Ensure compliance with regional regulations and company SOPs.

• Maintain up-to-date knowledge of LATAM regulatory guidelines, including Module 1 (m1) requirements for submissions.

• Liaise with local health authorities, business partners, and internal teams (CMC, QA, PV, Medical Affairs).

• Support agency meeting preparations and GMP certification processes.

• Assess regulatory impact of manufacturing and quality changes.

• Define submission plans and timelines for change control activities.

• Hands-on experience with biosimilars submission.

Experience:

Minimum 4 years in Regulatory Affairs within the pharmaceutical/biotech industry

Job Summary:

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.

Responsible for:

• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio

• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products

• Collaboration with partners to develop and execute global regulatory activities

• DMF preparations, review of changes and routine updates to Global Regulatory Agencies

• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution

• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements

• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle

• Support development and execution of clinical/non-clinical strategies

• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration

• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans

• With minimal supervision, participate in development of risk management and contingency planning

• Ensure and lead regulatory compliance for biosimilar products

• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:

• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products

• Review and assess impact of regulatory decisions for competitive products

• Generate and communicate biosimilar intelligence Collaboration:

• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products

• Identify process needs to meet internal challenges

• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and

Skills

• Comprehensive understanding of Regulatory activities

• Regulatory experience with product filings

• Team skills, especially in working with internal and external partners

• Familiarity with project management requirements

• Ability to understand and communicate scientific CMC information

• Anticipate and prevent potential issues

• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission

Education

Doctorate degree OR Master's degree

Job Summary:

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.

Responsible for:

• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio

• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products

• Collaboration with partners to develop and execute global regulatory activities

• DMF preparations, review of changes and routine updates to Global Regulatory Agencies

• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution

• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements

• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle

• Support development and execution of clinical/non-clinical strategies

• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration

• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans

• With minimal supervision, participate in development of risk management and contingency planning

• Ensure and lead regulatory compliance for biosimilar products

• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:

• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products

• Review and assess impact of regulatory decisions for competitive products

• Generate and communicate biosimilar intelligence Collaboration:

• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products

• Identify process needs to meet internal challenges

• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and Skills

• Comprehensive understanding of Regulatory activities

• Regulatory experience with product filings • Team skills, especially in working with internal and external partners

• Familiarity with project management requirements

• Ability to understand and communicate scientific CMC information

• Anticipate and prevent potential issues

• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission

Education

Doctorate degree OR Master's degree

Job Summary:

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.

Responsible for:

• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio

• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products

• Collaboration with partners to develop and execute global regulatory activities

• DMF preparations, review of changes and routine updates to Global Regulatory Agencies

• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution

• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements

• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle

• Support development and execution of clinical/non-clinical strategies

• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration

• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans

• With minimal supervision, participate in development of risk management and contingency planning

• Ensure and lead regulatory compliance for biosimilar products

• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:

• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products

• Review and assess impact of regulatory decisions for competitive products

• Generate and communicate biosimilar intelligence Collaboration:

• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products

• Identify process needs to meet internal challenges

• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and Skills

• Comprehensive understanding of Regulatory activities

• Regulatory experience with product filings • Team skills, especially in working with internal and external partners

• Familiarity with project management requirements

• Ability to understand and communicate scientific CMC information

• Anticipate and prevent potential issues

• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission

Education

Doctorate degree OR Master's degree

Job Summary:

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.

Responsible for:

• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio

• Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products

• Collaboration with partners to develop and execute global regulatory activities

• DMF preparations, review of changes and routine updates to Global Regulatory Agencies

• Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution

• Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements

• Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle

• Support development and execution of clinical/non-clinical strategies

• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration

• Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans

• With minimal supervision, participate in development of risk management and contingency planning

• Ensure and lead regulatory compliance for biosimilar products

• Participation in regulatory meetings with Health Authorities Regulatory Intelligence:

• Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products

• Review and assess impact of regulatory decisions for competitive products

• Generate and communicate biosimilar intelligence Collaboration:

• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products

• Identify process needs to meet internal challenges

• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and

Skills

• Comprehensive understanding of Regulatory activities

• Regulatory experience with product filings

• Team skills, especially in working with internal and external partners

• Familiarity with project management requirements

• Ability to understand and communicate scientific CMC information

• Anticipate and prevent potential issues

• Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission

Education

Doctorate degree OR Master's degree

JOB TITLE :
Regulatory Affairs - Senior Executive - ROW markets (Philippines, Kenya, Ethiopia, Nigeria)

WHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES?

As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training that teaches coaching skills, team collaboration, performance enhancement, as well as how to be an effective contributor. At Surgeway Biosciences, we offer much more than just a job. We strive to give you a Promising and Bright Career path.

PRIMARY GOAL FOR THE ROLE

Complete technical know how about dossiers, and dossier compilation
(for ROW markets)
- and generating new dossiers and reviewing existing dossiers, in a timely and accurate manner.

Roles & Responsibilities:

To prepare and compile a registration dossier as per the CTD / ACTD / Country specific guidelines -

specifically for ROW markets (Philippines, Nigeria, Zambia, Ethiopia, Kenya, Myanmar, Cambodia,)

Must be aware of the contents of a Dossier, and should be knowledgeable about all the documents attached in dossiers

To prepare, review /check artwork, pack insert, SmPC, etc.

To verify all technical documents and information received from various departments at the manufacturing site.

To verify specification of excipients, active, finished product, and packaging material

and all required documents.

Must be aware of Biosimilars/Drug products submission procedure for ROW countries

Must be aware of the ICH guidelines and the updates on the same

To reply to any queries raised by respective regulatory authorities, in a timely manner.

Maintains the highest level of submission standards.

Requirements:

Prefer professionals with experience in Dossier preparation and Submission-

for
ROW markets
(Especially South East Asia and East Africa)

Two to Three years' experience
in Pharma Regulatory Affairs will be preferred

Immediate Joining or 15-day's Notice Period
is preferred.

Candidate Profile:

M.Pharm candidate
with 2-3 years of experience in the
RA department (
for
ROW
countries)

Good communication skills in English

Ability to grasp new concepts quickly

Must have a systematic approach to solving problems.

Must be able to understand the techniques and processes used

Excellent PC skills, should be proficient with the usage of the internet as a tool to find

necessary and useful information.

Must be organized- timely, and with information/data.