Associate, Regulatory Affairs

1 day ago

hyderabad, India SteriMax Inc. Full time
Position Title: Associate, Regulatory Affairs
Reports To: Director, Regulatory Affairs
Location: Hyderabad, Telangana, India
POSITION DESCRIPTION
The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.
KEY RESPONSIBILITIES
- Provides cross-functional review and strategy from a regulatory, scientific and technical viewpoint.
- Coordinates the assembly, including requesting and/or generating, of documents to support submissions including generic injectables, and may also include complex generics and biosimilars per established business processes and systems
- Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters.
- Builds and maintains a healthy working relationship with business partners.
- Executes labelling activities, preparing the product monograph and coordinating the generation of mock-up artwork with senior artwork specialist
- Evaluates and ensures that submissions are accurate and meet format and content requirements as per Health Canada regulations, completing dossier publishing using eCTD software
- Completes RA impact assessments for change controls as necessary.
- Communicates effectively with internal departments (Product Development, Quality, Supply Chain, Marketing, etc.) to assist in the continuation of product supply
- Contributes to an efficient and effective regulatory affairs team and uses knowledge and expertise towards a culture of continuous improvement
- Maintains current awareness of Health Canada regulatory guidelines and shares knowledge with the department
TECHNICAL SKILLS:
- Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner
- Knowledge of GMP requirements and QA/QC procedures
- Strong understanding of Health Canada and ICH regulatory guidance documents and policies
- Proficient computer skills, including MS Office applications and Adobe Acrobat; Experience with eCTD publishing tools is an asset
- Demonstrated understanding of sterile product manufacturing is preferred
QUALIFICATIONS
- University Degree in Science or Life Sciences. Post-graduate certification in Regulatory Affairs program preferred.
- Must have a minimum of 3 years of experience with drug submissions for Health Canada. Sterile injectable experience preferred.
- Ability to work with changing priorities that involve multiple and concurrent projects.
- Excellent oral and written communication skills.
- Strong understanding of Canadian regulatory guidance documents and policies, as well as ICH and international guidelines.

  • Regulatory Affairs Associate

    5 months ago

    Hyderabad, India Parexel Full time

    Hyderabad, India **Job ID** R0000012328 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: **Regulatory Affairs Associate** Must have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned...

  • Associate, Regulatory Affairs

    22 hours ago

    hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

  • Associate, regulatory affairs

    2 days ago

    Hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

  • Associate, Regulatory Affairs

    2 days ago

    hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...

  • Associate, regulatory affairs

    2 days ago

    Hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...

  • Associate, Regulatory Affairs

    2 days ago

    Hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, India POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. KEY...

  • Associate, Regulatory Affairs

    3 days ago

    Hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

  • Associate, Regulatory Affairs

    2 days ago

    hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

  • Associate, Regulatory Affairs

    3 days ago

    Hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, India POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. KEY...

  • Associate, Regulatory Affairs

    3 days ago

    hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, India POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. KEY...

  • Regulatory Affairs Associate

    3 weeks ago

    Hyderabad, Telangana, India Makro Full time

    Job Title: Regulatory Affairs AssociateWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our team at Makro. The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions.Key Responsibilities:Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for...

  • Associate, Regulatory Affairs

    3 days ago

    Hyderabad, India SteriMax Inc. Full time

    Position Title:Associate, Regulatory AffairsReports To:Director, Regulatory AffairsLocation:Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...

  • Regulatory Affairs Associate

    2 weeks ago

    Hyderabad, Telangana, India Makro Full time

    Job SummaryWe are seeking a detail-oriented and proactive Associate Regulatory Affairs Publishing professional with 13 years of experience in regulatory submissions across global markets, including the US, UK, EU, and ROW. The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions.Key...

  • Regulatory Affairs Associate

    2 weeks ago

    Hyderabad, Telangana, India Makro Full time

    Job Summary: We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our team at Makro. The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions.Key Responsibilities:Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various markets, including...

  • Regulatory Affairs Associate

    3 weeks ago

    Hyderabad, Telangana, India Makro Full time

    Job Summary:We are seeking a detail-oriented and proactive Associate Regulatory Affairs Publishing professional with 13 years of experience in regulatory submissions across global markets, including the US, UK, EU, and ROW. The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions. This role is...

  • Regulatory Affairs Associate

    3 weeks ago

    Hyderabad, Telangana, India Makro Full time

    Job Summary:We are seeking a detail-oriented and proactive Associate Regulatory Affairs Publishing professional with 13 years of experience in regulatory submissions across global markets, including the US, UK, EU, and ROW. The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions. This role is...

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, Telangana, India Medtronic Full time

    Job Title: Regulatory Affairs SpecialistMedtronic is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Global Operating Unit, you will be responsible for ensuring compliance with regulatory requirements and ensuring the successful launch of our medical devices.Key Responsibilities:Prepare, review, and submit...

  • High Salary: Associate, Regulatory Affairs

    2 days ago

    Hyderabad, India SteriMax Inc. Full time

    Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...

  • Regulatory Affairs Manager

    2 weeks ago

    Hyderabad, Telangana, India Imaging Endpoints Full time

    Job DescriptionImaging Endpoints is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Compliance and Regulatory Affairs department, you will be responsible for assisting the Compliance and Regulatory Affairs Management in executing day-to-day tasks associated with managing, maintaining, and continually improving...

  • Regulatory Affairs Specialist

    4 days ago

    Hyderabad, Telangana, India TeizoSoft Private Limited Full time

    About the JobThe Regulatory Affairs Manager will play a crucial role in ensuring compliance with global regulations and policies for TeizoSoft Private Limited. This position requires a strong understanding of regulations and policies issued by India, US FDA, and EU, as well as the ability to interpret international regulatory requirements.Key...