DOSSIER CREATION / CMC WRITER REGULATORY AFFAIRS - SCIENTIST

We are looking talents for our Interlomas’ General Offices for the position of.
Dossier Creation / CMC Writer Regulatory Affairs - Scientist Management full time position.
Start date.
As soon as possible.
Qualifications.
2-4 years experience with Science or Pharmacy degree.
The Technical Author (TA) / CMC Scientist, individual is responsible for preparing & approving submission ready documents for renewals, variations or rollouts, i.
.
maintain existing products licenses for medicinal products (MP) or Food Supplements (FS), i.
.
playing an active role in the framework of dossier preparation and submissions.
In the space of Base Business in Latin America.
Part of the role is to plan authoring, coordinate and create all technical regulatory documents for submission to worldwide Health Authorities to secure products in the market (Module 2.
and Module 3), or to maintain FS Master dossiers.
Besides, proactively managing technical authoring and regulatory compliance activities in close collaboration with a multifunctional team such as RA (Regulatory Affairs), MPD (Development of Materials & Packaging) and QA (Quality) is required.
The collaboration and Talent guidance in global, multi-functional teams are also components of this role as well as the responsibility to ensure regulatory requirements are met to facilitate continuous improvement and support projects within complex supply chains.
Scope of the role.
This role will focus on technical authoring in the area of Base Business with flow to work to innovation on a need base Does the technical writing for MPs (module 3 & 2.
) and (Master Dossier), i.
.
writes technical documentation in the required ‘regulatory language’ for submission to authorities Is accountable for the accuracy, completeness, and consistency of the content of the technical document and ensuring that it is aligned with the objective of the document type and classification Does the upload of documents into internal document management system (Veeva RIM) Owns the technical documentation for submission; coordinates and initiates the review & approval process and does approval for technical documents.
First point of contact for questions/ comments on a technical document (e.
.
formatting and/ or content perspective) when assigned as document owner Owns technical compliance (with manufacturers information/ raw data) Has functional expertise and preferably appropriate external accreditation, and is responsible for confirming that the content of the technical document for a scientifically sound What we offer you.
Responsibilities from Day 1 – You will start working for key service strategies for all our organizations from the beginning.
Continuous coaching & mentorship – We are passionate about our work.
We will make sure you receive both formal training and as regular mentorship from your manager and others.
Multifaceted and encouraging work environment – We live our Purpose, Values, and Principles daily.
We value every individual and encourage initiatives promoting agility and work/life balance.
Friendly and encouraging atmosphere at work.
Flexible work arrangements.
Wellness programs (anti-stress massage, yoga, nutritionist, medical checkup, daily balanced snacks) Competitive salary and benefits program - private life & medical insurance for employees and dependents, PG stock, saving plans.
Job Qualifications Eligibility to work in Mexico City (Interlomas).
2-4 years experience with Science or Pharmacy degree Excellent English verbal and writing skills.
Experience in a regulatory environment in a GPS (G lobal Product Stewardship) or QA role.
Initial experience in the field of marketing authorizations / registration of Food Supplement.
Knowledge about applicable Guidelines and Regulations for Medicinal products and Food Supplements in the Region Latin-America, and/or Document Management Systems would be beneficial.
Leadership skills – individual need to work and negotiate in multifunctional project teams and manage multiple priorities.
Ability to assertively communicate risks/ issues and drive action.
Ability to influence and develop others.
Discipline, individual must be able to develop a plan, focus on priorities, manage timelines, initiate actions and execute.
Strong collaboration skills – individual needs to partner across functions and regions.
Basic communication skills in Spanish and Portuguese are beneficial.
If you are interested, please JOIN US by submitting your application below! Follow us on Facebook.
https://www.
acebook.
om/pgmexico/ About Us.
We are an equal opportunity employer.
We don’t discriminate against individuals based on race, gender, age, citizenship, religion, sexual orientation, gender identity or expression, disability, or any other legally protected factor.
Our people are all equally hardworking in outstanding ways.
we come from diverse traditions, personal experiences and points of view.
And we want to include yours.
Are you ready to encourage us with your ideas? Job Schedule Full time Job Number R Job Segmentation Experienced Professionals (Job Segmentation)