CROMSOURCE

Regulatory Scientist, Georgia US - L

3 days left

Company
CROMSOURCE
Location
United States, Georgia, Smyrna
Salary
Competitive
Posted
23 Aug 2019
Closes
22 Sep 2019
Ref
HQ00001880
Hours
Part Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Description:
Regulatory Scientist

Location: Georgia - United States

TalentSource Life Sciences is currently searching for an experienced Regulatory Scientist to join one of our biotechnology partner companies in Georgia, United States. This is a full time, permanent opportunity where the successful candidate will be working on studies dedicated to one client.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

The Regulatory Scientist prepares and delivers regulatory operational plans for assigned projects/products within a specific region, in addition to strategic and operational regulatory input and guidance in cross-functional teams. The Regulatory Scientist manages quality regulatory submissions to agreed project targets and works flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.

Major Accountabilities and Responsibilities
  • Support the Global Regulatory Leader for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant procedures and regional/local country regulations.
  • Lead the planning, preparation and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
  • Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice.
  • Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.
  • Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents.
  • Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates.
  • Maintain awareness of competitors' activities and share potential impact these activities may have on the product development program.
  • Delivers project assignments supporting the business e.g. representation on functional workstreams.
  • Ensure that appropriate, up-to-date records are maintained for compliance.
  • Assist in development of regulatory standards and SOPs.
  • Provide input into Regulatory Strategy Plans and project budget as delegated
  • Assist in due diligence activities for in-licensing opportunities.


Required Skills, Qualifications, Experience:
  • Proven pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation.
  • Albility to build effective partnerships; identifies opportunities and takes actions to build effective relationships within team and with other areas.
  • Strong influencing skills; through well thought through rationale and effective communication skills, able to influence key decisions.
  • Flexibility and adaptability; decides what to do based on the situation. Changes behavior or approach to fit the situation or the person. Works effectively in ambiguous situations.
  • Communication skills; knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Results focused; ability to overcome obstacles and achieve key outcomes
  • Analytical; logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
  • Strong organizational skills
  • Integrity; overriding commitment to integrity and high standards in self and others


If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001880

If you would like to discuss the role before applying through the website, please contact holly.price@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE?

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Keywords: Regulatory Affairs, Reg Affairs, Regulatory Scientist, Biotechnology, Biotech, Pharmaceutical, Outsourced, Permanent, Full Time
Skills: Regulatory Affairs Associate, Regulatory Affairs Manager, Regulatory Location: United States, Georgia, Smyrna

Similar jobs

Similar jobs