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LifeScience Regulatory Svs Associate

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Accenture

1mo ago

  • Job
    Full-time
    Junior & Mid Level
  • Healthcare

AI generated summary

  • You need a Master of Pharmacy and 1 to 3 years of relevant experience.
  • You will handle regulatory operations tasks, perform document QC, build dossiers, ensure compliance with regulations, and support biopharma submissions within a team environment.

Requirements

  • Master of Pharmacy
  • 1 to 3 years

Responsibilities

  • You will be aligned with our Life Sciences R&D vertical.
  • Our services span across the entire life sciences enterprise and regulatory services.
  • Employees under this span will be a part of the sub-offerings Regulatory, helping the world s leading biopharma companies bring their vision to life drugs enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.
  • The incumbent will perform the regulatory operations tasks for life cycle maintenance (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents.
  • Perform Quality Control (Document QC) checks for all submission components.
  • You will be expected to collect, collate and evaluate and build dossiers.
  • Ensure the organization`s products comply with current regulations.
  • Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc.
  • 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.

FAQs

What is the required qualification for the LifeScience Regulatory Svs Associate position?

The required qualification is a Master of Pharmacy.

How many years of experience are needed for this role?

The role requires 1 to 3 years of experience.

What will my primary responsibilities be in this position?

Your primary responsibilities will include performing regulatory operations tasks for life cycle maintenance of submissions, conducting document quality control checks, collecting and evaluating data, building regulatory dossiers, and ensuring compliance with regulations.

What kind of work environment can I expect?

You can expect to work as part of a team, primarily interacting with your own team and direct supervisor, with detailed guidance provided for tasks.

Will I be working independently or as part of a team?

You will be an individual contributor as part of a team, focusing on a predetermined and focused scope of work.

Are there any specific tools or platforms I will need to work with?

Yes, you will be expected to build regulatory dossiers using the Veeva Regulatory Module.

Does this role require working in shifts?

Yes, this role may require you to work in rotational shifts.

What industry does this position primarily support?

This position primarily supports the life sciences industry, particularly in regulatory services for biopharma companies.

What is the main goal of the regulatory services team?

The main goal of the regulatory services team is to help leading biopharma companies bring their vision to life by improving outcomes and converging around the patient experience.

Technology
Industry
10,001+
Employees
1989
Founded Year

Mission & Purpose

Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations Services, and Accenture Song—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities.

Culture & Values

  • Client Value Creation

    Enabling clients to become high-performance businesses and creating long-term relationships by being responsive and relevant and by consistently delivering value.

  • One Global Network

    Leveraging the power of global insight, relationships, collaboration and learning to deliver exceptional service to clients wherever they do business

  • Respect for the Individual

    Valuing diversity and unique contributions, fostering a trusting, open and inclusive environment and treating each person in a manner that reflects Accenture’s values.

  • Best People

    Attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a “can-do” attitude and fostering a collaborative and mutually supportive environment.

  • Integrity

    Being ethically unyielding and honest and inspiring trust by saying what we mean, matching our behaviors to our words and taking responsibility for our actions.

  • Stewardship

    Fulfilling our obligation of building a better, stronger and more durable company for future generations, protecting the Accenture brand, meeting our commitments to stakeholders, acting with an owner mentality, developing our people and helping improve communities and the global environment.

Benefits

  • Medical coverage

    Employees have a choice of national plans (PPO, EPO, HDHP) covering a wide range of medical services and prescription drugs.

  • Parental leave

    16 weeks paid maternity leave for birth parents. 8 weeks paid time off for other parents

  • Flexible work arrangements

    Flexible work arrangements help employees achieve work/life balance while also meeting Accenture’s business needs.

  • Paid time off

    PTO encompasses traditional vacation time along with paid sick leave; days vary based on level and tenure from 17 to 27 per year.

  • Holidays

    We provide 8 paid standard holidays and 2 culture days (for any days you choose), in addition to the PTO program.

  • Life Insurance

    Accenture provides you with a basic level of coverage and you can purchase more coverage for yourself and your family.