Regulatory Affairs Specialist - Pharma

Our team in South Plainfield currently has an opening for a Regulatory Affairs Specialist - Pharma

YOUR ROLE & RESPONSIBILITIES

• Supporting the regional Pharma division Sales Team on topics including regulatory, legal, compliance, quality and product safety.

• Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA's & TA's) in and English.

• Contribute as part of team to maintenance of EMEA document management system to keep product and supplier information up to date.

• Request product and supplier information directly from manufacturers and indirectly via other internal channels.

• Process Change Control Notifications.

• Maintain customer specific information such as completed questionnaires, supply chain agreements, QAA's, TA's in the designated database.

• Creation and ongoing update of product regulatory information in standardized information packs.

• Support of customer, regulatory and 3rd party audits.

• Reporting and documenting customer requests via KPIs.

YOUR PROFILE

Education and Experience:

• 2 years previous experience working with regulatory documentation.

• Knowledge of ISO9001, food safety or GxP systems.

• University degree in life sciences

• Knowledge of pharmaceutical industry requirements and regulations on APIs, Excipients and starting materials.

• Previous experience with the FDA (or another national competent authority) and their requirements.

• Team player, strong communication and interpersonal skills, with ability to work across all levels, and functions

OUR OFFER

We aim to create an environment where the best people want to work, where they can turn their passion into their job and realize their full potential.Individual development, on-the-job training, and development programs designed to help our employees grow in their careers.Competitive pay and incentives.Various healthcare plan options as well as 401(k).

INTERESTED?

We look forward receiving your application.

Brenntag provides equal employment opportunities to qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other status protected by applicable federal, state or local law.

Brenntag North America, Inc. and its subsidiaries use E-verify, a government-run, web-based system that allows employers to confirm the eligibility of their employees to work in the United States. For more information, please go to https://www.e-verify.gov/employees or view the poster at https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster.pdf.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability

to access job openings or apply for a job on this site as a result of your disability. You can request reasonable accommodations by contacting Human

Resources at accommodations@brenntag.com.