Regulatory Affairs Associate

hace 2 días

San Vicente Ferrer, Colombia GSK A tiempo completo

In GSK Consumer Healthcare, we are on an incredible journey as we prepare to create a new, standalone, world leading company with a 100% single-minded focus on everyday health. We are doing this at a time when the work we do has never mattered more. With the COVID pandemic, people are increasingly looking for ways to manage their own health and wellbeing and to take care of their families. This is where we come in. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we are uniquely placed to deliver better everyday health to millions of people around the world and grow a strong, successful business. This is an opportunity to be part of something special.”

This position is Multilocation

As a, we empower you to be yourself, share ideas and work collaboratively.

**_
Your Responsibilities:_**

This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:

Proactively manage impact of regulatory changes within defined scope of responsibility on the business.
- Analyze regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs. Look for opportunities with regional supportive team to reduce submission/ approval timelines. At the same time complying with our internal policies and local regulations
- Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance.
- Correct handling and timely updating of regulatory systems such as Veeva Regulatory, local databases, and other systems with regulatory information with high impact to the business such as SAP.
- Give support to other deparments: Permanent interaction as regulatory reference for Sales, Marketing, Customer Supply Chain, Medical, Demand and Legal to assure the business continuity and for any activity where regulatory support is required
- To review and approve promotional materials of products under his/her responsibility so that these materials are in accordance with health regulations.
- To participate in labelling process reviewing and approving the artworks of the products under his/her responsibilities, providing the input from the regulatory perspective and assuring the artworks are in accordance with health regulations
- To interact with Health Authorities, local registrations contact and regulatory associations. If required

**_
Why you?
- **

**Basic Qualifications**:
We are looking for professionals with these characteristics to achieve our goals:

- Pharmaceutical degree is required.
- English and Spanish level: advanced.
- 3+ years of experience in similar roles with demonstrated success in managing health registrations processes for Central American and Caribbean and desirable in other Latam countries meeting high standards of quality
- In
- depth knowledge of the current health regulatory framework for drug regulatory procedures.

**_
Inclusion & Diversity at CH:_**
**Inclusion and diversity at GSK are key for our success.** Here, you will thrive through bringing your **unique experiences** to both our company and the recruitment process. We want you to **be you, feel good and keep growing your career.**
**GSK is an Equal Opportunity and Affirmative Action Employer.** Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. **Beyond this, we commit to our values of integrity and respect towards every applicant.**
**We want to hear from you and support with** **any adjustments that you may require during the recruitment process.** Please get in touch with our Recruitment Team to further discuss this today.
- Important notice to Employment businesses/ Agencies_

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