LifeScience Regulatory Svs Associate

Skill required: Regulatory Services - Life Sciences Regulatory Operations

Designation: LifeScience Regulatory Svs Associate

Qualifications: Bachelor of Pharmacy/Master of Pharmacy

Years of Experience: 1 to 3 years

What would you do
You will be aligned with our Life Sciences RD vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance Regulatory, helping the world

s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.
Regulatory Services involves helping organizations comply with laws and regulations. This role includes providing guidance on regulatory requirements, preparing necessary documentation, and submitting reports to regulatory authorities. It also involves staying updated on regulatory changes and conducting compliance audits. The goal is to ensure the organization meets all legal and regulatory obligations efficiently.
Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.

What are we looking for

Ability to establish strong client relationship

Ability to handle disputes

Ability to manage multiple stakeholders

Ability to meet deadlines

Adaptable and flexible

Roles and Responsibilities:

In this role you are required to solve routine problems, largely through precedent and referral to general guidelines

Your expected interactions are within your own team and direct supervisor

You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments

The decisions that you make would impact your own work

You will be an individual contributor as a part of a team, with a predetermined, focused scope of work

Please note that this role may require you to work in rotational shifts

Qualification Bachelor of Pharmacy,Master of Pharmacy