Regulatory Affairs Specialist
3 weeks ago
Job Title:Senior Regulatory Affairs Executive
Location: Dadar
Yr of Exp-10+
Mandatory-Only Candidates from Pharma Co and that too into Formulation ,Pls apply for this job
Key Responsibilities:
Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.
Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance.
MOH Query Response: Address and respond to any Ministry of Health (MOH) queries for dossiers submitted in the relevant territories.
Compliance: Review product artworks and samples to ensure compliance with regulatory requirements.
International Coordination: Liaise with international agents for dossier submission, follow-up, and product registration.
Documentation: Maintain comprehensive records of technical documentation, product registrations, and related expenses.
Team Management: Lead and manage the regulatory affairs team, ensuring deadlines and regulatory goals are met.
Requirements:
Proven expertise in the regulatory field of pharmaceutical finished formulations for CIS, LATAM, and African markets.
Experience in compiling and reviewing ACTD and CTD dossiers.
Proficiency in handling MOH queries and ensuring timely responses.
Strong attention to detail in checking product artwork and samples for regulatory compliance.
Ability to effectively coordinate with international agents and manage the dossier submission and registration processes.
Solid organizational skills for maintaining technical documentation and tracking expenses.
Team management
-
Regulatory Affairs Specialist
2 days ago
Mumbai, Maharashtra, India Seven N Half Full timeAs the Regulatory Affairs Specialist at Seven N Half, you will play a pivotal role in ensuring that our operations align with regulatory requirements. This includes managing the compliance team, monitoring regulatory updates, and conducting compliance testing.Key Areas of Focus:Regulatory Compliance & Monitoring: Track regulatory changes and ensure timely...
-
Regulatory Affairs Officer
2 weeks ago
Mumbai, Maharashtra, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeDesignation : Regulatory Affairs Specialist Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 10 years of experience in regulatory affairs Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities : Regulatory Compliance : Ensure company products comply with...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India DigiFocal IT Solutions Pvt Ltd Full timeSenior Regulatory Affairs Executive Location: Dadar Years of Experience: 10+ Mandatory Requirements: Candidates from Pharmaceutical Companies with Formulation experience. Key Responsibilities: Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa. Dossier Management: Compile and...
-
Regulatory Affairs Officer
3 weeks ago
Mumbai, Maharashtra, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeDesignation : Regulatory Affairs SpecialistQualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistryExperience : Minimum 2-5 years of experience in regulatory affairsSalary : 5 lpaLocation : Sandhurst Road Mumbai - Head officeEssential Duties and Responsibilities:- Regulatory Compliance: Ensure company products...
-
Regulatory Affairs Executive
2 weeks ago
Mumbai, India Morpheus Human Consulting Full timeReference Code: - 319-54 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Our client is one of the leading Manufacturing company of Animal Healthcare Products since 1977. They have around 20 dedicated sales offices in India. - They market wide range of poultry and cattle products....
-
Regulatory Affairs Officer
2 weeks ago
Mumbai, Maharashtra, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeDesignation : Regulatory Affairs SpecialistQualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistryExperience : Minimum 10 years of experience in regulatory affairsLocation : Sandhurst Road Mumbai - Head officeEssential Duties and Responsibilities:Regulatory Compliance: Ensure company products comply with...
-
Regulatory Affairs Specialist
4 weeks ago
Mumbai, India Tata Consultancy Services Full timeTCS is hiring for Regulatory Affairs Role !!!Location: MumbaiExperience: 5 to 8 yearsJob Description:1) Minimum 5 to 8 Years experience in Regulatory Affairs with minimum 2 Years direct exposure in Regulatory Publishing.2) Candidates should have hands-on experience in eCTD, CTD, ACTD, NeeS submission Experiences.3) Candidates must be exposed with IND,...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, India Tata Consultancy Services Full timeTCS is hiring forRegulatory Affairs Role !!!Location:MumbaiExperience:5 to 8 yearsJob Description:1) Minimum 5 to 8 Years experience in Regulatory Affairs with minimum 2 Years direct exposure in Regulatory Publishing.2) Candidates should have hands-on experience in eCTD, CTD, ACTD, NeeS submission Experiences.3) Candidates must be exposed with IND, NDA, BLA,...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, India DigiFocal IT Solutions Pvt Ltd Full timeJob Title:Senior Regulatory Affairs ExecutiveLocation: DadarYr of Exp-10+Mandatory-Only Candidates from Pharma Co and that too into Formulation ,Pls apply for this jobKey Responsibilities:Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.Dossier Management: Compile and review ACTD and...
-
Regulatory Affairs Specialist
11 hours ago
Mumbai, Maharashtra, India Genpact Full timeAbout the RoleAs a key member of our team, you will play a pivotal role in shaping our regulatory strategy and ensuring compliance with global regulations. Your expertise in CMC regulatory affairs will be instrumental in driving our business forward.This position requires a strong understanding of ICH guidelines, FDA regulations, and other relevant laws and...
-
Regulatory Affairs Officer
3 weeks ago
Mumbai, Maharashtra, India Orbitouch Outsourcing Pvt ltd Full timeDesignation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 8 years of experience in regulatory affairs Salary : As per industry Location : Sandhurst Road Mumbai - Head office **Job Summary**: **Essential Duties and Responsibilities**: -...
-
Regulatory Affairs Specialist
4 weeks ago
Mumbai, Maharashtra, India Tata Consultancy Services Full timeTCS is hiring forRegulatory Affairs Role Location:MumbaiExperience:5 to 8 yearsJob Description:1) Minimum 5 to 8 Years experience in Regulatory Affairs with minimum 2 Years direct exposure in Regulatory Publishing.2) Candidates should have hands-on experience in eCTD, CTD, ACTD, NeeS submission Experiences.3) Candidates must be exposed with IND, NDA, BLA,...
-
Regulatory Affairs
3 weeks ago
Mumbai, Maharashtra, India Sensys Technologies Pvt. Ltd Full time**Job Summary**: We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The requirements for our products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes. Essential Duties and Responsibilities: **Regulatory Compliance**: Ensure company products comply with...
-
Regulatory Affairs Executive
3 weeks ago
Mumbai, Maharashtra, India CP HR Services Pvt.Ltd Full time**Company Name**: Anmol Chemicals - **Designation** **:Regulatory Affairs Specialist** - **Qualifications**: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry - **Experience**: Minimum 2-5 years of experience in regulatory affairs - **Salary**: Good Hike on Current CTC - **Location**: Sandhurst Road Mumbai - Head...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, India DigiFocal IT Solutions Pvt Ltd Full timeJob Title:Senior Regulatory Affairs Executive Location: Dadar Yr of Exp-10+ Mandatory-Only Candidates from Pharma Co and that too into Formulation ,Pls apply for this job Key Responsibilities: Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa. Dossier Management: Compile and review...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India DigiFocal IT Solutions Pvt Ltd Full timeJob Title:Senior Regulatory Affairs ExecutiveLocation: DadarYr of Exp-10+ Mandatory-Only Candidates from Pharma Co and that too into Formulation ,Pls apply for this job Key Responsibilities:Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.Dossier Management: Compile and review ACTD and...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India DigiFocal IT Solutions Pvt Ltd Full timeJob Title:Senior Regulatory Affairs ExecutiveLocation: DadarYr of Exp-10+Mandatory-Only Candidates from Pharma Co and that too into Formulation ,Pls apply for this jobKey Responsibilities:Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.Dossier Management: Compile and review ACTD and...
-
Regulatory Affairs Officer
3 weeks ago
Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeDesignation : Regulatory Affairs SpecialistQualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistryExperience : Minimum 2-5 years of experience in regulatory affairsSalary : 5 lpaLocation : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities:Regulatory Compliance: Ensure company products...
-
Regulatory Affairs Officer
3 weeks ago
Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeDesignation : Regulatory Affairs Specialist Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 2-5 years of experience in regulatory affairs Salary : 5 lpa Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities : Regulatory Compliance : Ensure company...
-
Designation: Regulatory Affairs
1 week ago
Mumbai, India Actide International Full timeThey must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions are full time. Regulatory Responsibility means a duty or responsibility, assigned to an individual...