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Regulatory Submissions Associate I

Covance 11/8/2018 4:54:31 AM
JOB ID: 24531 Category: Regulatory
Maidenhead, United Kingdom



Job Overview


Covance is expanding and is recruiting a Regulatory Submission Associate I based at our office in Maidenhead. The role is responsible for providing support to regulatory managers and others for the timely submission of information to Regulatory Authorities in support of investigational and marketed products. The position interacts with Regulatory Authorities and clients to support regulatory activities. You will proactively interact with other Covance groups and with clients to provide guidance regarding Regulatory Authority requirements and project timelines and requirements. It is the responsibility of the Regulatory Associate to prepare documents to the required standard and to maintain awareness of current regulatory standards related to submissions for drug and biologic products.

Essential Job Duties

♦ Assist in the preparation of submissions filed to Regulatory Authorities (e.g.: INDs, CTAs, NDAs, NDSs, MAAs or CTDs).

♦ Contribute to the preparation of submissions to Regulatory Authorities by reviewing/summarizing scientific/research documents.

♦ Assist in the coordination, collection and organization of information required by Regulatory Authorities.

♦ Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.

♦ Maintain knowledge and awareness of regulations and guidelines pertaining to drugs and biologics.

♦ Monitor compliance with regulatory requirements in relation to assigned projects.

Company information

A career at Covance provides our employees the unique chance to create an immediate impact and difference in our patient's lives. Joining Covance will offer a rewarding career, a chance to work in a high-energy & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you'll be empowered to own your career journey with mentoring, training and personalized development planning. As a Covance employee, your work will be meaningful, the patient outcomes are real, and the results are lasting.

Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Education / Qualifications

Education/Qualifications /Certifications and Licenses


♦ Bachelor's Degree in Life Sciences or equivalent


Experience :

* Excellent communication skills, organization and planning skills and a high attention to detail.
* Must have Experience in the pharmaceutical industry with previous regulatory affairs Experience

Position Type: Full-Time

Location: Maidenhead, UK - United Kingdom


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).