Senior Manager Regulatory Affairs

Sunrise Remedies Job Opening for Regulatory Affairs (RA). **Experience**: Minimum 2 Years **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad. **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices,...

Job Description Job Description Job Description: In this role, you will lead a Regulatory Affairs Team for our Magnetic Resonance Imaging (MRI) Business Unit, Bangalore & Pune. You will also be accountable for developing and deploying innovative, compliant regulatory strategies to grow and sustain the MRI portfolio. This portfolio spans imaging medical...

Apsida Life Science has partnered with a leading biotech company who are looking for a Regulatory Affairs ConsultantThe Regulatory Affairs Consultant is required to support CMC activities in drafting submission dossiers for new vaccines.Key Responsibilities:Prepare IND and IMPD DS & DP for Phase I/II/III studies, ensuring alignment with appropriate templates...

OverviewAt Naari Pharma Pvt Ltd., we are seeking a highly skilled Regulatory Affairs Executive to join our team.

Manage QMS & regulatory affairs strategies & submissions. Internal/External Audits & distributor audits,manage product registrations, import licenses & other approvals, Maintain PMS Data, Query resolving raised by DCGI, BIS, Customs or ADC port etc. **Department** All Departments **Open Positions** 1 **Skills Required**: Quality Assurance;Regulatory...

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...

Regulatory Affairs expertise with medicinal products for changes with impact on Product Information - Safety / Labelling changes, including CCDS creation or updates Experience:1. 8-9 yrs of Regulatory Affairs experience in EU/UK/CH/AU/NZ:- Safety Labelling changes with impact on Product Information and management of AW updates from an RA perspective- CCDS...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our Compliance Department at ICICI Prudential Life Insurance. The successful candidate will play a key role in ensuring that our organization remains compliant with regulatory requirements and industry standards.The ideal candidate will have excellent communication and...

How You Contribute:Manage the full life cycle of regulatory submissions for Emerging and Regulated markets, covering pre- and post-approval processes, including initial submissions, query responses, variations, renewals, and post-approval maintenance.Independently prepare, compile, and submit high-quality regulatory dossiers that meet country-specific...

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...

The Regulatory Affairs Specialist will play a key role in ensuring compliance with regulatory requirements for Clini Launch Research Institute.Key ResponsibilitiesPrepare registration dossiers for procuring certificates/license from local FDA, DCGI and FSSAI.Confirm product formula and label acceptability, as well as the receipt of necessary licenses, prior...

About ImmuneelImmuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please referwww.immuneel.comWe Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our...

About ImmuneelImmuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please referWe Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and...

Parexel is seeking a highly skilled Regulatory Affairs Consultant to join our team.Key Responsibilities:- Lead on Safety Labelling changes with impact on Product Information and manage AW updates from a regulatory perspective- Create or update Centralized Computer System Data Sheets (CCDS) with prior experience being preferable- Conduct thorough change...

Job DescriptionSite Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, Rockville Vaccines, Waltham Posted Date: Feb 4 2025 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines...

About the Role:We are seeking an experienced Regulatory Affairs Specialist to join our team, focusing on the submission and maintenance of Biologic products in various markets. The ideal candidate will have a strong understanding of regulatory guidelines and frameworks, as well as experience with Regulatory Information Management Systems like Veeva Vault.The...

Job ObjectiveTo device Government Defence Business Development and Corporate Affairs efforts. This role involves building and maintaining strategic relationships at all levels with government stakeholders, defense agencies, and industry partners, with a focus on driving growth in the defense sector. Identify business opportunities, managing proposals and...

Clini Launch Research Institute seeks an Executive - Regulatory Compliance to join our team.Job SummaryThis position will ensure timely and robust functional/cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution and implementation of regulatory affairs and safety processes.ResponsibilitiesDevelop and implement...

Job description-4+ yrs experience of authoring, compiling and submission of country-specific submission files (MAA, and post-approval changes) of Biologic products in various markets - Regulated (EU/US/Canada) and Emerging Markets. Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more...

**About the Role**We are seeking an exceptional compliance professional to join our team as Chief Compliance Officer. As a key member of our leadership team, you will play a critical role in ensuring that our business operations are compliant with relevant laws and regulations.This is a fantastic opportunity to take your compliance career to the next level...