Current jobs related to Regulatory Compliance Team Lead Expert - Hyderabad, Telangana - Amgen
-
Regulatory Compliance Expert
4 days ago
Hyderabad, Telangana, India Corteva Full timeAbout the Job: We are looking for a talented Regulatory Compliance Expert to join our team at Corteva. As a Regulatory Compliance Expert, you will play a critical role in ensuring that our operations comply with all relevant regulations and standards.Key Responsibilities:Manage Regulatory Data: Manage Material Data Governance Process to ensure continued...
-
Regulatory Compliance Team Lead
1 week ago
Hyderabad, Telangana, India Amgen Full timeCareer Category Regulatory The Regulatory Compliance Team Lead will be responsible for overseeing a team of regulatory CMC professionals performing assessment of operational changes for regulatory reportability for Amgen products across phases of development modality and countries This role is accountable for hiring training...
-
Offboarding Team Lead
4 days ago
Hyderabad, Telangana, India Tide Full time**Offboarding Team Lead - Compliance and Efficiency Expert**Tide is a place where diverse backgrounds and experiences enrich our culture. We're committed to transparency and inclusivity, ensuring everyone's voice is heard.We're looking for a highly skilled Offboarding Team Lead to oversee the involuntary offboarding and account closure process, ensuring...
-
Regulatory Compliance Manager
7 days ago
Hyderabad, Telangana, India Novartis Full timeJob Description:The position of Regulatory Compliance Manager at Novartis is a critical role that requires a professional with expertise in regulatory affairs. The ideal candidate will have a strong background in chemistry, manufacturing, and control (CMC) regulations, as well as experience in preparing and submitting regulatory documents to health...
-
Regulatory Compliance Director
5 days ago
Hyderabad, Telangana, India Piramal Pharma Ltd Full timeKey ResponsibilitiesThe Head of Quality Assurance will be responsible for the following key responsibilities:Leading the Quality Assurance team to ensure compliance with regulatory requirements.Developing and implementing quality systems and procedures.Providing guidance and support to employees on quality-related issues.Coordinating audits and inspections...
-
Regulatory Compliance Specialist
7 days ago
Hyderabad, Telangana, India Piramal Pharma Ltd Full timeAbout the Job:We are seeking a highly experienced Head Quality to join our team at Piramal Pharma Ltd. As a key member of our senior management team, you will be responsible for ensuring that our organization meets the highest standards of quality and regulatory compliance.You will develop and implement quality policies and procedures, lead the quality...
-
Global Quality Compliance Expert
3 days ago
Hyderabad, Telangana, India Novartis Full timeJob Overview:Novartis is seeking a Global Quality Compliance Expert to join our team. In this role, you will be responsible for ensuring the quality and compliance of our products. You will develop and execute global CMC regulatory strategies, lead CMC submission activities, and identify and address content quality and timeline issues for global...
-
Compliance and Advisory Expert
3 days ago
Hyderabad, Telangana, India D V Rao & Associates Full timeD V Rao & Associates is seeking a highly skilled Compliance and Advisory Expert to join our team. As a key member of our Corporate Secretarial Firm, you will be responsible for ensuring compliance with regulatory requirements and providing expert advice on various transactions.Key Responsibilities:Ensure compliance with regulatory bodies such as NCLT, RBI,...
-
Risk and Compliance Expert
3 days ago
Hyderabad, Telangana, India IQ-EQ Full timeCompany OverviewIQ-EQ is a leading service provider to the alternative asset industry. Our team works with managers in multiple capacities, ranging from hedge fund, private equity fund, and mutual fund launches; private equity fund administration; advisory firm set-up, regulatory registration, and infrastructure design; ongoing regulatory compliance;...
-
Hyderabad, Telangana, India Compliance Group Inc Full timeWe are looking for a talented Life Sciences Veeva Systems Professional to join our team at Compliance Group Inc. As a key member of our team, you will be responsible for ensuring the smooth operation of our Veeva Vault System.The successful candidate will have a strong background in life sciences compliance and computer systems validation requirements, as...
-
Regulatory Compliance Specialist
7 days ago
Hyderabad, Telangana, India Medtronic Full timeAbout Us: Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. Our mission is to unite a diverse team of passionate people to generate real solutions for real people.Job Description:We are seeking a Regulatory Compliance Specialist to join our team at Medtronic. As a key member of our...
-
Regulatory CMC Lead
4 days ago
Hyderabad, Telangana, India Novartis Full timeAbout the Role:As a Regulatory CMC Lead at Novartis, you will play a critical role in ensuring the quality and compliance of our products. You will be responsible for developing and executing global CMC regulatory strategies, leading CMC submission activities, and identifying and addressing content quality and timeline issues for global submissions.The ideal...
-
Expert Medical Regulatory Writer
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Expert Medical Regulatory Writer Job Location: Hyderabad, Telangana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Main ResponsibilitiesWrite and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization...
-
Hyderabad, Telangana, India Bristol-Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Quality Compliance Lead, Pharmacovigilance Expert to join our team at Bristol-Myers Squibb. This individual will be responsible for providing quality oversight through ongoing monitoring of safety outputs created by WWPS to ensure continuous compliance and quality excellence with all applicable safety guidelines and...
-
Regulatory Affairs Expert
7 days ago
Hyderabad, Telangana, India Dr. Reddy's Laboratories Full timeAbout the RoleWe are seeking a highly motivated Regulatory Affairs Expert to join our team at Dr. Reddy's Laboratories. In this role, you will be responsible for supporting the EUG PV activities, including managing the EU RMP and UK RMPs, handling RMP queries, and ensuring all activities are tracked through the maintenance of activity tracking...
-
Regulatory Labeling Expert
4 days ago
Hyderabad, Telangana, India Novartis Full timeCompany Overview">At Novartis, we strive to reimagine medicine and improve people's lives. Our Development Team is guided by a purpose to optimize processes, invest in new technologies, and build capabilities to bring medicines to patients faster.We are seeking key talent to join us and help give people with disease and their families a brighter future. As...
-
Regulatory Reporting Expert
7 hours ago
Hyderabad, Telangana, India Goldman Sachs Full timeWe are looking for a highly motivated and detail-oriented individual to join our Regulatory Operations Bangalore team. As a Regulatory Reporting Expert, you will play a critical role in ensuring that our firm meets its regulatory reporting obligations globally.Your primary responsibilities will include developing expert knowledge of regulatory requirements,...
-
Regulatory Compliance Manager
5 days ago
Hyderabad, Telangana, India Promea Therapeutics Full timeAbout Promea Therapeutics">Promea Therapeutics is a leading biotechnology company dedicated to developing innovative in-vitro diagnostic, large volume parenteral, and cyto-biological products. Our mission is to improve human health through the development of safe and effective products.">Job Description">We are seeking an experienced Quality Assurance...
-
Regulatory Compliance Change Assessor
3 weeks ago
Hyderabad, Telangana, India Amgen Full timeLet's do this. Let's change the world. In this vital role you will report into the Regulatory Compliance Team lead.The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product....
-
Regulatory Compliance Change Assessor
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Regulatory Compliance Change Assessor - Manager Job Location: Hyderabad, Telangana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Let's do this. Let's change the world. In this vital role you will report into the Regulatory Compliance Team lead.The Regulatory Compliance Change Assessor will interface with...
Regulatory Compliance Team Lead Expert
1 week ago
The Regulatory Compliance Team Lead will oversee a team of regulatory CMC professionals responsible for assessing operational changes for regulatory reportability across Amgen's product development phases, modalities, and countries. This role is accountable for hiring, training, and retaining talented regulatory CMC staff in alignment with the operational objectives of the wider RA CMC department.
Key Responsibilities
* Oversight of regulatory CMC teams performing assessment of operational changes for regulatory reportability
* Hiring, training, and retaining talented regulatory CMC staff
* Continuous improvement through process development and refinement, as well as partnership with colleagues in other functions to develop systems and tools that improve speed and efficiency
Requirements
* CMC-specific regulatory knowledge and experience with solid working knowledge of product lifecycle changes impacting CTAs and MAs
* Understanding and application of principles, concepts, theories, and standards of scientific technical field
* Experience managing execution of multiple projects
* Knowledge and understanding of different phases of drug development
* Results-oriented and track record of completing deliverables on time with high quality
Education and Experience
* Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and 8 years of directly related experience
* Degree in life sciences, biochemistry, or chemistry
* Experience in manufacture, testing, or distribution of clinical and commercial products or related Quality or Regulatory CMC functions in Pharmaceutical Biotech industry
* Regulatory CMC experience and biologics experience preferred
About Amgen
Amgen is a leading biotechnology company focused on developing innovative human therapeutics based on advances in molecular biology and recombinant DNA technology.
