Sr Associate Regulatory Writing

2 weeks ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 8,00,000 - ₹ 12,00,000 per year

Roles & Responsibilities:

  • Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g.
  • Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
  • Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
  • Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues
  • Record and maintain written redaction strategy for the study and product
  • Support trend analysis and process improvement
  • Execute clinical trial disclosure business process and ensure
  • delivery in compliance with regulations, Amgens policy and SOPs/ and guidance documents
  • Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilities
  • Assist/support trial disclosure audits and inspections
  • Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution
  • Generate /manage reports, trackers, portals and metric activities

Required Skills:

  • Experience understanding and interpreting data/information and its practical application
  • Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
  • Ability to follow controlled processes
  • Excellent spoken and written English
  • Ability to communicate and negotiate to influence stakeholders
  • Project management skills, including ability to prioritize work in order to meet required deadlines
  • Problem solving ability

Basic Qualifications:

  • Bachelors degree
  • Minimum of 2 years experience in preparing regulatory documents for public disclosure
  • Understanding of clinical research and clinical regulatory documents
  • Working knowledge of clinical trial disclosure regulations, guidelines, and best practices

  • Sr Associate Regulatory Affairs

    2 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams toOptimize product development and regulatory approvals in International countriesDevelop...

  • Regulatory Affairs Sr Associate

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable...

  • Sr Associate Regulatory Writing

    13 hours ago

    Hyderabad, Telangana, India Amgen Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years...

  • Regulatory Affairs Associate

    4 days ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Sr Associate Regulatory Affairs Career CategoryRegulatory Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the...

  • Associate Regulatory Writing

    2 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Roles & Responsibilities:Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional teamEnsure consistent quality across documents, ensure submission readiness, and...

  • Associate Regulatory Writing

    10 hours ago

    Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years...

  • Regulatory Writing Senior Manager

    2 weeks ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 10,00,000 - ₹ 25,00,000 per year

    Senior Manager, Global Regulatory Writing Career CategoryRegulatory Job Description At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's...

  • Regulatory Affairs Associate

    2 weeks ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Sr. Associate Regulatory Affairs Career CategoryRegulatory Job Description Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of...

  • Senior Manager, Global Regulatory Writing

    2 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 5,44,000 per year

    What you will doIn this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standardsWrite or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4)Write CTD sections including the Summary of...

  • Prod Compliance Associate Sr

    2 days ago

    Hyderabad, Telangana, India Amazon Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    "Please note that this job is a seasonal role (FTC) for 12 months on the payroll of Amazon."Job Description is looking for a smart, enthusiastic, hard-working, and creative candidate to join the Brand Protection Business Operations team as a Prod Compliance Associate Sr. This position offers an exciting introduction to the Amazon Marketplace and provides a...