Regulatory Affairs Associate, Post-Approval

2+ years

Not Disclosed

Hyderabad

15 June 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the job

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

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Regulatory Affairs Associate, Post-Approval

Job Description

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