
Regulatory Compliance Manager
2 days ago
About the Role:
We are seeking a Senior Regulatory Affairs Specialist to join our team. In this role, you will be responsible for leading and managing regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.
Key Responsibilities:
- Manage regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.
- Oversee the compilation and submission of annual reports, amendments, and deficiency responses.
- Collaborate with cross-functional teams to gather required documentation and data.
- Ensure compliance of batch manufacturing records, process validation documents, and site-related data.
- Coordinate with manufacturing units to ensure product and process compliance with regulatory requirements.
- Stay up-to-date on evolving USFDA regulations and provide strategic guidance.
Required Skills and Qualifications:
- 7-10 years of experience in Regulatory Affairs - CMC with USFDA filings (especially ANDAs).
- Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
- Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
- Exposure to quality systems and interacting with production/plant teams.
- Ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA.
What We Offer:
Our company offers a dynamic work environment, competitive salary, and opportunities for professional growth and development.
-
Regulatory Compliance Officer
2 weeks ago
Ahmedabad, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 60,00,000 - ₹ 1,20,00,000Job Title: Regulatory Affairs SpecialistWe are seeking a detail-driven and meticulous individual to support the regulatory compliance activities for Class III medical devices.The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers.You will collaborate with...
-
Regulatory Compliance Specialist
18 hours ago
Ahmedabad, Gujarat, India beBeeCompliance Full time ₹ 25,00,000 - ₹ 35,00,000Regulatory Affairs ManagerThis role focuses on ensuring the timely and compliant preparation of dossiers for regulatory submissions.The Regulatory Affairs Manager will work closely with internal stakeholders to ensure that all submissions are in line with current regulatory guidelines and client expectations.Key Responsibilities:Prepare and review...
-
Regulatory affairs manager
1 day ago
Ahmedabad, Gujarat, India Red Envelope Consultants Full timeKey Responsibilities:Dossier Preparation & Review: o Prepare and review CTD/e CTD/non-CTD dossiers for new product registrations, renewals, and variations for Ro W markets (e.g., Africa, Southeast Asia, CIS, LATAM).Ensure dossiers are in line with current regulatory guidelines and client expectations.Regulatory Submissions & Approvals: o Coordinate with...
-
Regulatory Affairs Manager
3 days ago
Ahmedabad, Gujarat, India Red Envelope Consultants Full timeKey Responsibilities:Dossier Preparation & Review: o Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for RoW markets (e.g., Africa, Southeast Asia, CIS, LATAM).Ensure dossiers are in line with current regulatory guidelines and client expectations.Regulatory Submissions & Approvals: o Coordinate with agents...
-
Regulatory Affairs Manager
2 weeks ago
Ahmedabad, Gujarat, India Red Envelope Consultants Full timeKey Responsibilities:Dossier Preparation & Review: o Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for RoW markets (e.g., Africa, Southeast Asia, CIS, LATAM).Ensure dossiers are in line with current regulatory guidelines and client expectations.Regulatory Submissions & Approvals: o Coordinate with agents...
-
Compliance Manager
2 weeks ago
Ahmedabad, Gujarat, India Magadh Capital Full timeWhat does the job entailEnsuring the firm's compliance with legal/regulatory procedures, preparation and filing of reports with regulatory agencies as required , co-ordinating audits with external vendors, regular follow up on changes in regulations, working with Company Secretary and CA to ensure compliance with ROC and IT procedures, Coordinating with fund...
-
Senior Manager Regulatory Affairs
3 days ago
Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full timeDesignation: Regulatory Affairs ManagerIndustry: Medical Devices (Orthopedic devices preferred)Experience required: 10 to 15 YearsLocation: Sanand, AhmedabadCompany overview:A globally‑recognized orthopedic medical device firm founded in 2003, delivering cutting-edge sports‑medicine and extremities implants and instruments across six continentsDriven by...
-
Senior Manager Regulatory Affairs
4 days ago
Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full timeDesignation: Regulatory Affairs Manager Industry: Medical Devices (Orthopedic devices preferred) Experience required: 10 to 15 Years Location: Sanand, Ahmedabad Company overview: A globally‑recognized orthopedic medical device firm founded in 2003, delivering cutting-edge sports‑medicine and extremities implants and instruments across six...
-
Regulatory Affairs Director
18 hours ago
Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 30,00,000 - ₹ 40,00,000Job Title: Senior Manager Regulatory AffairsAbout the Role:We are seeking a seasoned senior manager to lead our regulatory affairs team and spearhead compliance strategy for global markets.Key Responsibilities:Compliance Strategy Development: Develop and implement comprehensive regulatory compliance strategies tailored to meet global market...
-
Compliance Specialist
1 day ago
Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Compliance Officer - Asset Management ExpertJob Title: Compliance Officer - Asset Management ExpertEnsure ongoing adherence to regulatory requirements and internal policies.Monitor and interpret changes in relevant laws, regulations, and guidelines applicable to asset management.File mandatory regulatory reports within stipulated timelines.Key...