Associate II-Publishing & submission

Designation: Associate-II (publishing & Submission)

Qualification(s)

Bachelors Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Masters Degree preferred for senior-level roles.

RAC certification is a plus.

Experience(s)

Minimum 3-6 years of relevant Regulatory Affairs experience required.

Familiar with the Life Sciences Industry, preferably Regulatory

Understanding of global regulations related to Pharmaceuticals, Medical Devices, and Biologics in the context of service offerings.

Experience in creating customer-facing materials.

Able to work independently.

Fluent in English

Technical Skills

• Hands-on experience related to Regulatory Processes including related IT systems including Document Level Publishing and Submission Level Publishing.
• DMS tools like Veeva Vault, CARA, D2 are preferred.

Soft Skills

Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Competencies

• Good Communication (Writing and Verbal)
• Customer Focused
• Drive to deliver superior quality proposals.
• Strong Time management

Personal Traits

Positive Attitude, Initiative and Commitment, Detailed Oriented, Team player, Focused and sincere, Perseverance

Roles and Responsibilities

• Member of the Centre of Excellence team responsible for the Lifecycle Management of assigned products.
• Document level Publishing: Author and Publish the technical regulatory documents based on the clients product requirements.
• Submission Level Publishing: Compiles the dossier in the required format for submission to the relevant agencies.
• Responsible for using and updating RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions.
• Manage various activities under product life cycle management (Registration, Variation, Renewals, and submission)
• Prioritize target activities and produce high-quality deliverables.
• Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables.
• Adherence to appropriate regulatory guidelines, departmental SOPs, and Client SOPs for the deliverables.
• Complete training provided by the Client, and regular self-trainings; archive training certificates/records.
• Assist and support internal audits performed by the Client.
• Support implementation of Regulatory Affairs systems as per Client or Partner projects.
• Understands and will abide by ISMS policy and processes of the company.

Note : For anyone above 5 years of experience should come with both Data Management (Veena skills preferred) and P&S background.