Regulatory Affairs Associate, Post-Approval

1 week ago

hyderabad, India SteriMax Inc. Full time

POSITION DESCRIPTION

Reporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is expected to interpret regulatory requirements, meet approval timelines for new product launches, and ensure that regulatory requirements are met in support of existing commercial products to Health Canada.

KEY RESPONSIBILITIES

  • Prepares generic drug product submissions for Health Canada (e.g. NCs, SANDSs, DINAs, etc.). Ensures that submissions are accurate and meet format and content requirements.
  • Reviews, evaluates, prepares, and files deficiency responses to Health Canada in a timely manner within given deadlines.
  • Evaluates change requests.
  • Reviews and contributes to implementation of post-approval changes of drug products.
  • Interprets scientific data and conclusions from CMC reports and summaries.
  • Attends, and may organize and facilitate, meetings and teleconferences with external partners and internal stakeholders to maintain progress of projects. Tracks and communicates critical attributes of projects to ensure accountability and efficiency.
  • Maintains a healthy working relationship with business partners. Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters from Regulatory Agencies.
  • Contributes to an efficient and effective regulatory affairs team, and uses knowledge and expertise towards a culture of continuous improvement.
  • Maintains current awareness of regulatory guidelines (Health Canada, ICH, FDA, etc.) and shares knowledge with the department.

TECHNICAL SKILLS:

  • Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner
  • 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

LEADERSHIP SKILLS:

  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
  • Capability to handle multiple priorities and balance work to achieve business goals
  • Demonstrated effective communication, and interpersonal skills on business commitments and project timelines

QUALIFICATIONS:

  • University Degree in Science or Life Sciences and post-graduate certification in Regulatory Affairs program
  • Prefer a minimum of 2 years of experience in drug submissions for Canada, preferably with parenteral dosage forms

  • Regulatory Affairs Associate, Post-Approval

    7 days ago

    Hyderabad, India SteriMax Inc. Full time

    POSITION DESCRIPTIONReporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is...

  • Regulatory Affairs Associate, Post-Approval

    7 days ago

    Hyderabad, Telangana, India SteriMax Inc. Full time

    POSITION DESCRIPTION Reporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is...

  • Regulatory Affairs Associate, Post-Approval

    1 week ago

    Hyderabad, India SteriMax Inc. Full time

    POSITION DESCRIPTION Reporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is...

  • Regulatory Affairs Associate

    2 weeks 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...

  • Regulatory Affairs Associate

    3 weeks ago

    Hyderabad, India Parexel Full time

    Regulatory Affairs AssociateAround 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of  drug products (small molecules as well as biologics) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to preparation...

  • Regulatory Affairs Associate

    2 months ago

    Hyderabad, India Parexel Full time

    Regulatory Affairs AssociateAround 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of  drug products (small molecules as well as biologics) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to preparation...

  • Regulatory Affairs Associate

    2 months ago

    Hyderabad, Telangana, India Parexel Full time

    Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Contribute to preparation...

  • Regulatory Affairs Associate

    7 days ago

    Hyderabad, Telangana, India Parexel Full time

    Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Contribute to preparation...

  • Regulatory Affairs Associate

    3 weeks ago

    Hyderabad, Telangana, India Parexel Full time

    Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Contribute to preparation...

  • Regulatory Affairs Associate

    7 days ago

    Hyderabad, Telangana, India Parexel Full time

    When our values align, there's no limit to what we can achieve. Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for...

  • Regulatory Affairs Associate

    2 months ago

    Hyderabad, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for...

  • Regulatory Affairs Associate

    3 weeks ago

    Hyderabad, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends, for...

  • Regulatory Affairs Associate

    2 months ago

    hyderabad, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Regulatory Affairs Associate Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends,...

  • Regulatory Affairs Associate

    7 days ago

    Hyderabad, Telangana, India Parexel Full time

    Hyderabad, IndiaJob ID R Category Regulatory / ConsultingABOUT THIS ROLE:Regulatory Affairs AssociateMust 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 deliverable(s) including:Submission...

  • Regulatory Affairs Manager

    3 days ago

    Hyderabad, India SteriMax Inc. Full time

    About UsSteriMax is the largest privately-owned injectable company in Canada. Our foundation rests upon the principles of providing high quality products, maintaining a reliable product supply, and supporting the needs of Canadian patients. For more details, please visit our website Responsibilities· Manages and provides leadership to an efficient and...

  • Regulatory Affairs Manager

    3 days ago

    Hyderabad, India SteriMax Inc. Full time

    About UsSteriMax is the largest privately-owned injectable company in Canada. Our foundation rests upon the principles of providing high quality products, maintaining a reliable product supply, and supporting the needs of Canadian patients. For more details, please visit our website Responsibilities· Manages and provides leadership to an efficient and...

  • Senior Regulatory Affairs Associate

    3 weeks ago

    Hyderabad, Telangana, India Parexel Full time

    Regulatory Affairs LabelingBachelor's Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)The...

  • Senior Regulatory Affairs Associate

    2 months ago

    Hyderabad, Telangana, India Parexel Full time

    Regulatory Affairs LabelingBachelor's Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)The...

  • Regulatory Affairs Manager

    1 week ago

    hyderabad, India SteriMax Inc. Full time

    About Us SteriMax is the largest privately-owned injectable company in Canada. Our foundation rests upon the principles of providing high quality products, maintaining a reliable product supply, and supporting the needs of Canadian patients. For more details, please visit our website Detailed Responsibilities · Manages and provides leadership to an...

  • Senior Regulatory Affairs Associate-Biologics

    1 month ago

    Hyderabad, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Senior Regulatory Affairs Associate Around 4-8 y ears of relevant experience in handling of pre and post approval life cycle management of drug products (Biologics) in various markets. Good understanding of regulatory framework, including regional trends, for various types of...