134 Regulatory Affairs 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

About Halma:

Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.

Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology.

For the last 42 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ≥ 5% every year– an achievement unrivalled by any company listed on the London Stock Exchange.

Why join us?

We are a Great Place to Work® certified organisation, with an employee centric culture anchored on autonomy, trust, respect, humility, work-life balance, team spirit, and approachable leadership.

We offer a safe and respectful workplace, where everyone can be who they ‘REALLY’ are, feel free to bring their whole selves to work and use their unique talents, knowledge, expertise, experiences, and backgrounds to create meaningful outcomes.

We nurture entrepreneurial spirits and empower them to think beyond the possibilities, to discover, shape and build their own unique stories. We promote and support non-linear career growth for the right talent.

We are simple, humble and approachable, and we believe in leadership at all levels to bring our purpose to life. Everyone at Halma India makes an impact, and so do you when you join us!

Responsibilities:

• Have regular meetings with international Regulatory Teams of Halma Companies to understand their evolving business needs wrt Indian market.
• Assist them in understanding the India MDR with clarity.
• Serve as a consultant, advisor and guide to the International Regulatory team with a solution orientation.
• Reach out to CDSCO or travel to Delhi for mtg with regulatory officers to seek clarification.
• Tap into External India MDR Consultant as and when required.
• Evaluate, Recommend, Implement and Use technology and platforms to manage licences and process flows for multiple Operating Companies within the Group.
• Minimise risk to business disruption from regulation.
• Agile and responsive to changing regulatory environment and evolving business needs.
• Use MTAI membership effectively for advocacy as well as position Halma’s point of view whenever required.
• In addition, there are regulatory license applications for PESO to be also managed with a list of documents.
• GEM portal registration for Halma companies based abroad including providing checklist, outlining process, following up for documents, submission of the same, and facilitating online video audits of the factories.

Critical Success factors :

• Executional Rigor, Due diligence wrt to Documentation, and Process Oriented for day-to-day MDR Licensing requirement.
• Understands varying needs across diverse stakeholders – especially different types of medical devices.
• Transparent and effective communicator with all stakeholders, and commercially savvy when recommending solutions.
• Deep and Clear understanding of evolving India MDR.

Qualifications:

• Degree in Regulatory Management.

Experience:

• Minimum 1 to 3 years of relevant experience.
• Core end-to-end experience in India MDR.
• Experience in Regulatory License platforms.
• Exposure to Legal Metrology & Labelling, UDI, MRP/Pricing/Trade Margins, Customs and other related operational issues.
• Exposure to European MDR and FDA would be advantageous.

About Halma:

Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.

Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology.

For the last 42 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ≥ 5% every year– an achievement unrivalled by any company listed on the London Stock Exchange.

Why join us?

We are a Great Place to Work® certified organisation, with an employee centric culture anchored on autonomy, trust, respect, humility, work-life balance, team spirit, and approachable leadership.

We offer a safe and respectful workplace, where everyone can be who they ‘REALLY’ are, feel free to bring their whole selves to work and use their unique talents, knowledge, expertise, experiences, and backgrounds to create meaningful outcomes.

We nurture entrepreneurial spirits and empower them to think beyond the possibilities, to discover, shape and build their own unique stories. We promote and support non-linear career growth for the right talent.

We are simple, humble and approachable, and we believe in leadership at all levels to bring our purpose to life. Everyone at Halma India makes an impact, and so do you when you join us!

Responsibilities:

• Plan, coordinate and prepare document packages for regulatory submissions and renewals with emphasis on EU Technical Files, MDSAP, and other regulated countries.
• Author Technical file documentation to support EU MDR requirements.
• Review product labelling (advertising, promotions, IFUs, claims, device labelling) for regulatory compliance.
• Contribute to complaint handling process and prepare/submit MDRs and Incidents to appropriate health authorities.
• Perform MDR gap assessments and remediation of MDD technical files.
• Provide Regulatory support to Manufacturing and R&D to perform significant change impact assessments. Participate in Change Review board to review and approve Engineering Changes.
• Develop and maintain Regulatory Information Management system.
• Co-author regulatory plans for new product introduction or product line extensions.
• Author Regulatory department procedures, templates.
• Provide guidance, training, and direction on regulatory topics to Microsurgical Technology teammates.
• Maintain annual facility registrations, device listing, GSI, and GUDID as required by US FDA.
• Perform other related duties as assigned.

Critical Success factors :

• In-depth knowledge of medical device regulations and standards, such as FDA QSR, MDSAP, ISO 13485, (EU) MDR 2017/745, and ISO 14971.
• Experience in Ophthalmology or surgical instrument field preferred.
• Experience in medical device development, quality assurance, or regulatory affairs is highly desirable.
• Strong analytical and problem-solving skills with the ability to assess complex technical issues.
• Excellent communication and collaboration skills to work effectively with cross-functional teams.
• Detail-oriented and well-organized, with the ability to manage multiple tasks and priorities simultaneously.
• Familiarity with documentation and submission requirements for regulatory bodies is an advantage.

Qualifications:

• BS/BA in Engineering, Life Sciences, or an equivalent technical field.
• MS in Regulatory Affairs or RA/QA certifications a plus.

Experience:

• 5-8 years of experience in Quality or a regulated industry is preferred.

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

Work Schedule
Other
Environmental Conditions
Office

Responsibilities:
The Regulatory Affairs Manager is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market, and for providing knowledgeable input to interdisciplinary the project teams and management.

• Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia, ensuring timelines and standards are met.
• Support the implementation of regulatory activities at the LSG Indian plant, ensuring compliance with QMS/GMP.
• Collaborate with R&D, operations, QA, and product managers to meet regulatory and compliance requirements.
• Conduct regulatory investigations and analyses, defining strategies and providing updates to cross-functional teams.
• Prepare and manage technical files/dossiers for regulatory products, supporting global registration applications.
• Lead local performance evaluations, tests, and clinical studies to support product registration in India.
• Participate in Animal Health regulatory submissions and support the distributed team as needed.
• Coordinate post-market surveillance, resolving technical complaints and implementing corrective actions.
• Review advertisement materials for compliance with MD/IVD regulations in South Asia.
• Analyze new and existing regulations, preparing impact assessments for LSG projects.
• Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization.
• Participate in regulatory/quality audits, exhibitions, and conferences.
• Establish and maintain a network with consultants, policymakers, and regulatory agencies, such as Indian CDSCO.
• Perform other tasks as assigned by the line manager.

Minimum Requirements:
Education and Qualifications:

• Bachelor's degree or higher in Engineering, Sciences, or Medicine.
• Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices, particularly with Indian CDSCO regulations.

Essential Skills and Abilities:

• Comprehensive understanding of regulations, standards, and guidelines for In-Vitro Diagnostic and Medical Devices, especially in South Asia and Indian CDSCO regulations.
• Acute awareness of regulatory changes and skilled in regulatory and strategic analysis.
• Strong planning and organizational skills for regulatory submissions and project management.
• Excellent communication skills, including written, verbal, and presentation abilities.
• Strong project management skills with the ability to lead regulatory projects.
• Strong analytical skills, proactive, and a resourceful problem solver.
• Ability to work effectively under pressure and manage flexible working hours.
• Comfortable with ambiguity and change, providing clear mentorship in uncertain regulatory environments.
• Experience in leading compliance activities, including post-market surveillance and advertisement review.
• Ability to establish and maintain a network with relevant consultants, policymakers, and regulatory agencies.
• Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.

1) Regulatory lifecycle of ISTS Projects

2) Handling Section 68 / Section 164 permits and approvals

3) COD, First Time Charging (FTC), Trial Runs, and ISTS Connectivity Agreements

4) Liaising with PGCIL, CTU, DISCOMs, and Government agencies

• Around 7-10 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
• Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
• Responsible for managing (Authoring and Review) of biosimilar investigational product submission such as IND & IMPD for USFDA, EMA
• Authoring, review, and submission of BLA/MAA of biosimilar dossiers for US/EU/ROW /India markets.
• Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
• Life cycle management (LCM) for approved products. (Annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN) / US and other ROW markets.
• Evaluation of change controls and deviations and defining regulatory strategy .
• Co-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible
• Develop up-to-date knowledge about regulatory guideline updates and applies regulatory requirements and their impact on submissions.
• Working experience in Regulatory Information Management Systems like Veeva Vault.
• Strong communications skills and ability to guide and mentor team members.
• Ability to work independently.
• Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.
• Authoring content of the label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
• Familiarity with EU Guidelines for QRD / Excipients.
• Artwork management for countries with label in English.

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