Regulatory Translation Coordinator

3 weeks ago

Hyderabad, Telangana, India Sandoz Full time
Job Description

Administrative support

- Performs general coordination and administrative tasks to support the Regulatory Translation Hub functioning.
- Grants access to relevant CO associates to hub repository folders and keeps access information updated.
- Organizes and archives documentation in team repositories, including dispatch emails and surveys as required.
- Ensures renewal of licenses regarding translation-related software and indexing tools, including Trados Studio, Verifika, and dtSearch
- Updates team lists and trackers, e.g. general job list, invoicing tracker, QC tracker, quality incidents tracker, email contact lists, CO job list tracker.
- Assists team members with the preparation of reports and presentations.

PO creation and invoice management

- Manages invoices and creates POs on behalf of the Head of regulatory translations.
- Maintain invoice records.
- Addresses invoicing-related matters with vendors or service providers.

Operational support

- In the absence of Regulatory translations project managers or at their request, assigns urgent jobs to appropriate vendors, and performs quick format checks on outsourced translations before delivery.
- Provides support with uploading and downloading files from relevant databases as necessary.

SKILLS

Qualifications and experience

- Certified Administrative Professional (CAP) certification or an equivalent administrative degree.
- Fluency in English (both written and spoken). Proficiency in other languages (optional)
- At least 3 years of administrative experience, especially in Regulatory Affairs.

Skills required

- Strong problem-solving skills.
- Proficiency in Office tools (Excel a must).
- Excellent organizational skills.
- Adaptability.
- Commitment to quality.
- Good interpersonal skills.
- Highly committed and team oriented.

Skills Desired

Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance

  • Regulatory Affairs Coordinator

    2 weeks ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 6,00,000 - ₹ 10,00,000

    Job SummarySeeking a highly skilled Regulatory Affairs Specialist to prepare, review, and maintain regulatory documents ensuring compliance with international guidelines and country-specific requirements.Key ResponsibilitiesScreen and analyze documents received for product registration requests as per country-specific guidelines.Prepare, compile, and review...

  • Regulatory Affairs Manager

    18 hours ago

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

    Career CategoryInformation SystemsJob DescriptionThe RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is...

  • Regulatory Specialist

    3 weeks ago

    Hyderabad, Telangana, India Sol-Millennium Medical Group Full time

    We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at...

  • Regulatory Specialist

    3 weeks ago

    Hyderabad, Telangana, India Sol-Millennium Medical Group Full time

    We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at...

  • Regulatory Specialist

    2 weeks ago

    Hyderabad, Telangana, India Sol-Millennium Medical Group Full time

    We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at...

  • Regulatory Affairs Manager

    3 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionThe RA CMC Manager is responsible for the execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products.The RA CMC Manager is responsible for communicating the...

  • Regulatory Compliance Professional

    2 weeks ago

    Hyderabad, Telangana, India beBeeCompliance Full time ₹ 40,00,000 - ₹ 80,00,000

    Job Title: Regulatory Compliance SpecialistAt our organization, we are seeking an experienced Regulatory Compliance Specialist to join our team. The ideal candidate will have a strong background in regulatory compliance and be able to ensure that all submissions are periodically uploaded in the appropriate format.We are looking for someone who is aware of...

  • Cmc regulatory specialist

    3 weeks ago

    Hyderabad, Telangana, India BeBeeRegulatory Full time

    Job Summary: -Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities. This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities: Develop a...

  • Global Regulatory Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeRegulator Full time ₹ 13,72,000 - ₹ 23,14,000

    Regulatory Oversight RoleThis is an exciting opportunity to work within a dynamic and global team that manages supervisory activities of regulators and related developments across regions.The role will involve managing and coordinating regulatory examinations, overseeing and managing regulatory issues and action plans in internal tracking systems, producing...

  • Cmc Regulatory Specialist

    3 weeks ago

    Hyderabad, Telangana, India BeBeeRegulatory Full time

    Job Summary: -Regulatory professionals who specialize in chemistry, manufacturing, and control (CMC) activities prepare and publish regulatory documentation for submissions to health authorities.This involves interacting with these authorities on CMC-related questions to support the launch of new products or existing ones.Key Responsibilities: Develop a...