Deputy Manager, Regulatory Affairs Injectable US Market

DescriptionKEY RESPONSIBILITIES: Your responsibilities include, but are not limited to: Prepare Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.Draft Pre-ANDA/Pre-IND/ScA meeting...

Role & responsibilitiesTo lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats.Responsible for final review of dossier before submission.Reviewing artwork for products as per relevant regulatory authority requirements.Coordination with F&D, QA, QC & Store for documentationIn-depth knowledge of pharmaceutical documentation &...

_**Regulatory Affairs Manager Responsibilities**_ - Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards. - Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization. - Collaborate with cross-functional teams including R&D, Quality...

Roles and ResponsibilitiesPrepare dossiers for US FDA, including CTD format.Ensure regulatory compliance with RA requirements.Manage parenteral products' dossier preparation and submission to regulatory authorities.Coordinate with cross-functional teams for injectable product development and registration.Track regulatory updates and maintain records in...

**Position**: Regulatory Affairs Specialist **Location**: Odhav. Ahmedabad **Department**: Regulatory Affairs **Reports to**: Regulatory Affairs Manager / Director Job Summary: Key Responsibilities: - **Compliance Monitoring**: Monitor changes in regulations and guidelines to ensure ongoing compliance with local and international regulations. -...

Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...

**Introduction**: We are seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz,...