Current jobs related to Regulatory Affairs Executive - Mumbai, Maharashtra - Illusion Dental Laboratory
-
Regulatory Affairs
3 weeks ago
Mumbai, Maharashtra, India CliniLaunch Research Institute Full timeJob DescriptionPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile...
-
Executive Regulatory Affairs
7 days ago
Navi Mumbai, Maharashtra, India METSL Full time ₹ 3,00,000 - ₹ 4,00,000 per yearDear Candidates,We have job opportunity for the position of Regulatory Affairs Executive & QMR in our leading manufacturing Medical Devices companies.Position:-Regulatory Affairs Executive & Quality Management RepresentativeExperience:-2 to 4 yrsGender:-Male/FemaleThe JD as follows:-· Maintain regulatory files. Maintain and update regulatory authorizations,...
-
Regulatory Affairs Manager
2 weeks ago
Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 14,40,000 - ₹ 21,60,000Job Title: Regulatory Affairs ManagerAbout the RoleThis is an exciting opportunity for a highly skilled Regulatory Affairs professional to join our organization and contribute to the success of our team. We are seeking an experienced Regulatory Affairs Executive to lead our regulatory strategy, manage regulatory submissions, and maintain strong relationships...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 28,00,000 - ₹ 35,00,000Regulatory Affairs Expert RoleMain Objectives of the Position:A highly skilled and knowledgeable professional contributor with in-depth knowledge in Regulatory Affairs. The position demands executing complex or specialized projects, adapting precedent, and developing innovative solutions to overcome traditional approaches.Key Responsibilities:Leads the...
-
Regulatory Affairs
1 week ago
Navi Mumbai, Maharashtra, India Peoplefy Full time&## ; We're Hiring: Regulatory Affairs – CMC Associate &## ; Location: Navi Mumbai &## ; Years of Experience:4+ years &## ; Work from Office &## ; Notice Period: Looking for immediate joiners Skills Required: &## ; Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field. &## ; 4+ years of experience in Regulatory Affairs...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Chemical Manufacturing Full timeJob Title: Senior Executive / Assistant Manager – Regulatory Affairs Location: Mumbai, India (On-site) Employment Type: Full-time | Permanent Experience Required: 3 to 8 years Industry: Chemicals | Pharmaceuticals | Food & Beverages Job Function: Legal | Quality Assurance | Regulatory Affairs Salary: up to 9 LPA About the Role: We are hiring for...
-
Regulatory Affairs Director
2 weeks ago
Mumbai, Maharashtra, India beBeeDirector Full time ₹ 2,00,00,000 - ₹ 2,50,00,000Job DescriptionThe role involves developing and executing regulatory strategies to ensure product compliance, acting as a key liaison with regulatory agencies, and collaborating with cross-functional teams.Key Responsibilities include:Submission Management: Preparation, review, and submission of regulatory documentation to health authorities in various...
-
Regulatory Affairs Specialist
7 days ago
Navi Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 6,00,000 - ₹ 8,00,000Regulatory Affairs SpecialistOur organization is seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of US FDA regulations and ICH guidelines.Key Responsibilities:• Develop and implement regulatory strategies for new and existing products• Collaborate with cross-functional teams to...
-
Required Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India NOVO Medi Sciences Pvt ltd Full time ₹ 7,00,000 - ₹ 9,00,000 per yearRequired Regulatory Affairs | Chembur Salary: Job Title: Regulatory Affairs Location: Chembur 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:...
-
Regulatory Affairs Expert
2 weeks ago
Mumbai, Maharashtra, India beBeeSpecialist Full time ₹ 15,24,000 - ₹ 2,01,12,000Job Description:We are seeking an experienced Regulatory Affairs Specialist to operate as an individual contributor under limited supervision. The role requires applying subject matter expertise in Regulatory Affairs to ensure compliance and successful product approvals. The ideal candidate will have the capacity to adapt their skills and knowledge to meet...
Regulatory Affairs Executive
2 weeks ago
Job Title: Regulatory Affairs
No of Vacancy: 1
Job Location: Andheri West
Years of Experience: 1-4 years
Working Days: Monday to Saturday
Job Summary:
We are seeking a motivated and detail-oriented
Regulatory Affairs Executive
to join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with domestic and international regulations across global markets including India, the US, and the EU. This role requires strong coordination skills and a proactive approach to support product registrations, audits, and technical submissions.
Key Responsibilities:
Conduct
gap analysis
of existing regulatory and technical documentation.
Prepare and maintain regulatory submissions including:
l Device Master Files
l Risk Management Files
l Design History Files
l Clinical Evaluation Reports
l Usability Reports
Draft and update product labeling content such as
Instructions for Use (IFUs)
,
implant cards
, and
declarations
to meet global compliance requirements.
Support
regulatory submissions
for India (via CDSCO/SUGAM/NSWS), US (FDA), EU (CE marking under MDR), and other applicable markets.
Coordinate with cross-functional teams including
Purchase, Accounts, Legal, Marketing
, and
R&D
to gather documentation and resolve queries.
Assist in preparing and submitting responses for
audit-related queries
and regulatory inspections.
Contribute to regulatory strategy for
new product developments
and modifications.
Stay updated with changes in regulatory requirements and industry trends through self-learning and structured training.
Educational Qualifications:
Bachelor's or Master's degree in
Pharmaceutical Sciences
,
Engineering
,
Biotechnology
,
Microbiology
, or a related life science field.
Specialization in
Regulatory Affairs
or
Quality Assurance
preferred.
Experience:
1 to 4 years
of industry experience in a Regulatory Affairs role, preferably in medical devices, pharmaceuticals, or life sciences.
Hands-on experience with global and domestic regulatory submissions.
Exposure to documentation systems and regulatory portals (CDSCO/SUGAM/NSWS) is essential.
Experience or knowledge of
software regulations
is an added advantage.
Key Skills and Competencies:
Strong knowledge of:
Regulatory frameworks
including ISO 13485, EU MDR, and 21 CFR Part 820
Risk management
,
design controls
, and
post-market surveillance
Excellent
documentation, analytical
, and
technical writing skills
Proficient in
Microsoft Office Suite
and digital documentation platforms
Strong interpersonal skills to collaborate with internal departments and external bodies
Soft Skills:
Go-getter attitude
with the willingness to lead and take initiative
High
English proficiency
– both verbal and written
Strong
organizational
and
time management
skills
Ability to work independently and as part of a
cross-functional team.
Fast learner with a proactive mindset for continuous development.
Monday to Saturday working
