Regulatory Affairs Associate

0-1 years

Not Disclosed

12 April 9, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

About Mint Pharmaceuticals Inc.

Canadian owned and operated, Mint Pharmaceuticals Inc. ("Mint") is a leading manufacturer of high quality and affordable generic pharmaceutical products. With a focus on consistent supply, innovation and exceptional customer service, Mint aims to deliver the highest value to patients across Canada. Mint has repeatedly been recognized as one of the leading generic companies in Canada and most reputable pharmaceutical companies in Canada. Since 2014, the company has averted 19 national drug shortages on 13 different drugs through its best-in-class supply chain management. The company was recognized by Deloitte and CIBC as one of Canada's Best Managed Businesses since 2019.

JOB DESCRIPTION

Position: Regulatory Affairs, Associate, India

Reports to: Head of Regulatory Affairs, Corporate, Canada

Location: India

Primary Functions:

We are currently seeking a self-motivated individual to join the Regulatory Affairs team. The successful candidate will be a critical team member responsible for preparation and submission of various regulatory submissions (primarily CMC documents) for new or marketed generic products to Australia, Europe, Health Canada, MHRA-UK, USFDA or external stakeholders. This is a remote position based in India and offers a great opportunity for professional development with an established and rapidly growing Canadian company.

Roles and Responsibilities:

Manage and lead the team on New Generic Product Registrations, Labeling and Post approval submissions with Australia, Europe, Health Canada, MHRA-UK, USFDA. Work closely with leadership team at headquarters to ensure timely workflow and meeting of timelines.
Development and maintenance of excellent working relationships with global regulatory agencies, aiding in the potential reduction of filing requirements and timeliness of approvals, which significantly impact on the company’s competitive position within the industry.
Train fellow Associates on Regulatory due diligence, API selection pathway, submission strategies, CEP requirements, parameters impacting Drug Product formulation, Clinical studies overview and assisting them in career growth.
Perform gap analysis on dossiers to identify weakness and provide mitigation strategy for submission to regulatory Agencies.
Communication and coordination with partners/manufacturers to obtain supporting documents for ANDS submission. Giving scientific insight on New Product development and Technology Transfer Projects.
Responsible for assessing, coordinating and compiling deficiency responses in a timely manner to deficiency questions from Health Agencies.
Prepare product labelling and Patient Information Leaflet, as well as related items
Responsible for post-market product administration, participating in the review and evaluation of planned changes for impact on regulatory submissions, identifying regulatory filing requirements and recommending regulatory agency and customer notification strategies/plans in the affected regulatory jurisdictions.
Prepare SOP’s and work instructions, training programs on new regulatory guidelines, GMP, database management. Work closely with all functional groups (Canadian regulatory affairs, Business Development, Legal, Production, Quality, R&D) within and outside (manufacturing partners) the company to ensure all regulatory obligations are met.
Manage collaborations with external partner sites for new projects. Serve as main point of contact with third-party manufacturers for the projects led.
Maintain awareness of current regulatory environment and guidelines that impact the organization and share knowledge with internal stakeholders, as required.
Remain up to date on applicable regulatory guidelines (global regulatory, ICH, etc.).

Major Tasks:

Submissions

Review dossiers shared by partner companies for global regulatory submissions for completeness, accuracy and compliance with regulatory requirements and providing feedback to partners.
Review Drug Master Files and provide gap assessments to partners.
Preparation of global regulatory submissions (CTD format) including compiling, writing, and publishing
Timely preparation and filing of submissions to support company needs.

New Product Assessments/ Product Launches

Monitoring product development activities by interacting contract developers and manufacturers as necessary against identified submission targets.
Provide impact regarding formulation of drug development, clinical development etc. Initiation of Change Controls for changes from submission documents to launch documents, for handover to Quality Department.

Bioequivalence Studies

Coordination and Support with CRO as needed for global BE studies.

Labelling

Review and approve artwork routings of labelling.

Compliance

Ensure continual regulatory compliance of all products due to changes initiated from regulatory agencies (e.g. Labeling, Quality, changes)
Help to develop and oversee procedures and processes within Regulatory Operating Procedures to ensure compliance applicable regulations (e.g. Working Instructions are up to date, SOPS are followed etc.)
Assist in development and maintenance of accurate databases
Oversee the timely preparation of activities for other functional groups (SAP codes creations, launch documentation packages

Skills & Qualifications:

Bachelor of Science (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry or related Health Sciences
6-8 years of experience in the regulatory affairs field
Must have strong technical knowledge of CMC requirements and is able to critically analyze scientific data.
Strong knowledge of CTD requirements for global drug submissions.
Strong hands-on experience with writing sections of the CTD (with focus on CMC)
Knowledge of electronic submissions, including e-publishing (e.g., Docubridge)
Strong interpersonal skills and ability to foster strong working relationships with key stakeholders (internally and externally)
Strong working knowledge of global regulatory, Food and Drug Regulations, GMPs, ICH Guidelines
Ability to prioritize workload to ensure all deadlines are met
Excellent organization, written and oral communication skills
Ability to effectively manage multiple projects in a fast-paced, results oriented environment
Strong commitment to quality, accuracy, and detail
Ability to work well under pressure in a team-based environment

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