Detailansicht des Stellenangebots

Stellendetails zu: Regulatory Affairs Specialist (m/w/d) - befristet auf 2 Jahre

Regulatory Affairs Specialist (m/w/d) - befristet auf 2 Jahre

Kopfbereich

Arbeit
Ingenieur/in - Pharmatechnik
Regulatory Affairs Specialist (m/w/d) - befristet auf 2 Jahre
ThermoFisher (Kandel) GmbH
Vollzeit
Kandel, Pfalzab sofortbefristet für 24 Monatevor 30+ Tagen

Stellenbeschreibung

Job available in 2 locations: Kandel, Karlsruhe

Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our team of more than 100,000+ colleagues deliver an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD

Regulatory Affairs Specialist (m/w/d) - fixed term 2 years
Site: Kandel

Discover Impactful Work
The Regulatory Affairs Specialist is primarily responsible for ensuring compliance of the Laboratory Chemicals Division with global regulations with a focus on European legislation, particularly REACH and REACH-like regulations. Collaborating with a team of Chemical Regulatory Specialists, you will combine knowledge and expertise of scientific & regulatory issues to guide and support internal and external partners

A Day in the Life

  • Serves as EU & UK REACH subject matter authority, leading discussions with sourcing / data holders / co-registrants / product management to address regulatory obligations
  • Provides guidance on relevant chemical legislation including RoHS, CLP, BPR etc.
  • Partners with business leads & regulatory colleagues to develop regulatory strategy to enable global commercialization
  • Monitors emerging chemical regulations, assesses impact and develops strategy to address with relevant partners
  • Collaborates in regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed
  • Provides advice and support to all customers to ensure an outstanding customer experience.

Keys to Success:
Education

  • Minimum requirement of a university degree in a chemical or related field

Experience

  • Minimum regulatory experience in product stewardship / regulatory affairs / compliance / chemical consultancy / risk assessment
  • Experience of the implementation of European chemical legislation including drug precursors, PIC, explosive precursors, ODS etc.
  • Experienced in EU REACH compliance & a competent user of IUCLID / REACH IT
  • Experienced in UK REACH implementation including DUIN submissions.
  • Experience in multiple aspects of product stewardship, including risk assessment, hazard classification & labelling and other related topics

Knowledge, Skills, Abilities

  • Positive demeanour and approach
  • Excellent written and verbal communication skills, including presentation skills. Ability to communicate clearly, succinctly and effectively in person, over the phone, on remote meetings and in writing
  • Able to connect with all levels within the organization
  • Experienced project manager
  • Strong interpersonal skills including the ability to remain calm, professional and positive
  • Ability to work as a member of a team in a fast-paced environment with moderated supervision
  • Highly motivated, possessing strong organisational skills and able to prioritise multiple activities concurrently

We offer

  • Employment with an innovative, future-oriented organization.
  • Outstanding career and development prospects.
  • Company pension scheme.
  • Exciting company culture which stands for integrity, intensity, involvement and innovation.

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of color, religion, ___ orientation, gender identity, national origin, disability or any other legally protected status.

Apply today! http://jobs.thermofisher.com

Agency notice:
Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.

Arbeitsorte