Specialist Regulatory Affair ADCs

Job Summary

We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Antibody drug conjugates (ADC) technology typically has a role that involves ensuring compliance with regulatory requirements for ADC products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation, addressing deficiency letters, contributing to regulatory strategy development, and facilitating effective communication with stakeholders for successful product approvals, launches and regulatory compliance. Roles & Responsibilities

• You will be primarily responsible for handling the new DMF submission, Life cycle management globally for ADC products.

• Ensure that all ADC products comply with local, national, and international regulations and guidelines.

• You will act as primary interface between the technical teams and regulatory function and will be responsible to show the direction to technical writing teams on ensuring alignment with the requirements & regulatory needs for ADC products. Job Information

• You should have knowledge on US submission procedures, European registration procedures and regulatory submission procedures globally.

• You should ensure that all ADC products comply with local, national, and international regulations and guidelines.

• You will be responsible for preparation, review and submission of Drug Master Files for all regulated and non-regulated markets as per the applicable regulatory guidance.

• You will be responsible authoring high-quality chemistry, manufacturing, and controls (CMC) documentation for health authorities’ submissions, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance throughout the project lifecycle for ADC products.

• You will be responsible to maintain and update regulatory files, including submissions, approvals, and renewals.

• You should collaborate with cross-functional teams to gather necessary documentation and information for regulatory submissions.

• You will be responsible to review of critical quality/regulatory documents like specifications, controls strategy for impurities, stability data, development report as per Quality by Design (QbD) requirements, justification reports etc.

• You will be responsible for on time Response to deficiency letters.

• You will responsible for preparing Regulatory strategy notes, regulatory due diligence and gap analysis for leverage products. Evaluating and sharing the Regulatory Affair requirements with product development teams at the product introduction stage, performing regulatory due diligence and consolidated gap analysis for leveraging.

• You will be responsible for Communication/ Correspondence from regulatory Health authorities for the preparation and review of Scientific advices meeting packages.

• You will be responsible for identifying all open issues and anticipated questions on regulatory submission at respective stage of product development, DMF filing and deficiency responses in consultation with team leads.

• You will be responsible to review and closure of change control notifications (CRNs) for under development, under review and launch products in consultation with team lead.

• You will be providing launch support w.r.t key regulatory decisions.

• You will be responsible for ensuring regulatory compliance of drug products by meeting to current requirements of the regulatory agency.

• You will be responsible to interact with Internal and External stakeholders/customers and provide timely regulatory guidance on various issues.

• You will be responsible to take up the correspondence with the Agency globally to understand the specific regulatory requirements for ADC products.

Qualifications, Experience , Skills & Attributes Educational qualification- MSc. (Molecular biology, Genetics, Biochemistry or relevant filed) Minimum work experience- 6-8 years of experience in Regulatory affairs

Skills & attributes –

Technical Skills-

• Understanding of Good Manufacturing practice/Quality Systems.

• Understanding of product development, manufacturing processes, Intellectual Property and quality.

• Knowledge on post approval submissions requirements like variations, Renewals for European countries

• Sound knowledge of International Council for Harmonisation (ICH) / European Medicines Agency (EMA) guidelines/ US FDA guidelines/ China guidelines on submission requirements.

• Strong background in understanding the characterization strategy, impurity control strategy, analytical method validation strategy and specification strategy in ADC products.

• Proven experience in ADC technology and regulatory affairs. Behavioural Skills- • Excellent communication and interpersonal skills. • Efficient Leader and a good collaborator. • Effective planning and high level of performance orientation. • Strong analytical and problem-solving abilities.