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ProductLife Group

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3.7

based on 9 Reviews

5 ProductLife Group Jobs

Clinical Safety Associate- VAF 161

PRODUCTLIFE Group

3.7

based on 9 Reviews

1-4 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Clinical Safety Associate- VAF 161

ProductLife Group

posted 1d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Consulting Project Management Clinical Data Management Compliance Subject Matter Expertise

+ 2 more

Job Description

Role Description:

The Consultant works within the Regulatory, Quality & Compliance team delivering a range of regulatory applications within Australia, New Zealand, Japan, and the Asia Pacific (APAC) region. The Consultant manages client projects, working closely with other members of the team, to deliver a superior client experience, optimize project outcomes, and contribute to the culture and capabilities of the team.

Role Responsibilities:

General:

Adherence to ProductLife Group s values, policies, and quality management systems.
Provide high-quality work that contributes to client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering.

Project & Client Management:

Support regulatory activities requiring a sound knowledge of the type and quality of chemistry, manufacturing and controls (CMC), and clinical and non-clinical evidence necessary to support new medicines registrations and medical device inclusions, related life cycle management, and maintenance activities.
Provide support to clients on the registration and listing of pharmaceuticals and biologicals.
Review, critically evaluate, prepare, and submit regulatory dossiers to the regulatory agencies.
Participate in assigned projects and support project teams as requested.
Act as a subject matter expert.
Review and quality control (QC) applications, regulatory, quality, and compliance documentation as required.
Assist in the preparation of literature-based submissions, including the preparation of associated overviews and summaries.
Assist clients in responding to regulatory agency questions.
Assist clients with the maintenance of current registrations, listings, and inclusions.
Prepare and submit safety-related updates to Product Information documents at varying levels of complexity.
Attend meetings/teleconferences with clients and/or regulatory agencies as required.
Liaise with other groups within ProductLife Group as required.
Lead contributor to client retention by developing strong relationships with existing clients and providing high-quality consulting services to build client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the business unit s service offering.

Qualifications / Experience / Skills:

A bachelor s degree in science, pharmacy, or a related discipline.
A minimum of 5 years experience in regulatory affairs, preferably in a commercial environment.
Experience in the review, critical evaluation, and presentation of clinical data.
Good knowledge of legislation, regulations, guidelines, and working procedures within Australia, New Zealand, and the JAPAC region.
High-level written and oral communication skills.
Proven problem-solving and project management skills.
Reasonable computer literacy.
Ability to deal with a high level of confidentiality.
Post-graduate qualifications in a relevant discipline are desirable.
Previous experience in project management and/or consulting.