Lawsikho

Deadline Open Deadline

Location Hyderabad, Telangana

Salary The salary will be discussed with the candidate itself.

Details of the Organization

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 28 years of proven high-quality delivery and results across all their services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. They are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join their passionate team and make a meaningful impact on global healthcare!

Details of the Job/Internship

ClinChoice is a worldwide full-service Contract Research Organization (CRO) committed to fostering professional growth and ensuring an exceptional work-life balance. They cultivate a quality-driven, collaborative "one-team" culture. Currently, they are seeking a dynamic individual to join our in-house team as an Associate Manager in Regulatory Affairs (CMC) on a permanent basis. In this role, they will engage with projects from our diverse client base, spanning small to large pharmaceutical, biotechnology, medical device, and consumer health companies.

Come be a part of they team and contribute to making a meaningful impact in people's lives while enjoying a fulfilling and rewarding career experience!

Role and Responsibilities

Main Job Tasks and Responsibilities:

Prepare, review, and finalize the submission package of assigned product portfolios including new marketing authorization applications, post approval activities (Annual report, Renewals, Variations, supplements, amendments, PSUR etc), response to Health Authority questions for global markets.
Development / Execution of regulatory strategies and support product life cycle management.
Technical review of all quality and administrative documents in line with current quality guidelines.
Prepare gap assessment of existing documentation against the national regulations and provide remediation strategy to address the gap.
Coordinate with cross functional teams to collate required documentation.
Responsible for writing and review of CTD modules for all submissions.
Creation, review, assessment, and execution of initiated/assigned change controls.
Compliance to regulatory work processes, policies, and procedures.
Regular update of database, and tracking tools to ensure current product information is available.
Organizing and participating in project related meetings to provide status updates on the ongoing submissions and present dashboard on monthly metrics/SLAs.
Support for compliance activities.
Support in regulatory audits for manufacturing sites.
Keeping abreast of current regulations for global markets.
Functionally review the team’s work for accuracy and compliance.
Ensure proper planning of the deliverable and foresee any risks that are likely to arise.
Is accountable to ensure that team performs with compliance to accepted quality and turnaround thresholds.
Work closely with the team and client (as applicable) to identify and mitigate risks to meet the timelines, addresses/seeks clarity for queries, if any and escalates when necessary.
Ensure that all assigned goals (e.g., utilization and efficiency) are met for self and team as per set standards for the performance year.
Responsible for monitoring, ensuring training compliance and approving timesheets for team members.
Contribute to the preparation of RFI/RFPs/defense bid and act as a guide to the sales and business development team.
Constantly review process relating to the project and customer defined documentation as per internal guidelines.
Independently handle complex work-stream related queries from internal and external stakeholders – proactively providing solutions or answers to their queries.
Ensure all project and administrative documents are properly archived in the prescribed repositories.
Be aware of and comply with the QMS/ ISMS & PIMS Policy.
Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.
Contribute towards the achievement of Quality Objectives.

Eligibility

Education, Experience and Skills:

Doctorates OR Postgraduates in Life Sciences with minimum 12+ years of experience in Medical, Clinical & Regulatory writing in Pharma & Medical Devices space.
Should have at least 5+ years of experience in authoring clinical reports for Medical Devices.
Should have gained working experience on all class of devices across multiple therapeutic areas.
Should possess excellent verbal and written English communication skills.
Should have experience managing multiple teams and multiple projects / clients.
Should demonstrate coaching, mentoring & leadership qualities.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that they received it. If you have the requirements they need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications they receive, they cannot reply to everyone individually if you are not successful.