We have vacancy for Global Regulatory Expert role in Regulatory Affairs team.
We are looking for Executive/Sr. Executive. This individual will be based in
Mumbai/ Hyderabad. The candidate has the possibility to utilize his/her own
strengths with the support of the professionals.
Your key responsibilities
* Responsible for preparation / checking / review of pharmaceutical / quality
part (all forms) of registration dossiers and variations /amendments / annual
reports / renewals as applicable documents according to EU regulatory
requirements.
* To identify and classify the changes as per EU regulatory variation guidance.
* To prepare response to regulatory deficiencies letters according to EU
regulatory requirements
* To collaborate with other departments/partners
* To maintain lists/documents/records
* Responsible for keeping Orion internal regulatory system up to date and
accurate
* To achieve his/her responsibilities within the agreed timescales
* To actively participate in the development of regulatory skills within the
regulatory team by continuous up-dating
* Other possible tasks appointed by Supervisors
What we offer
* An excellent opportunity to work in an inspiring and important role in the
area of Regulatory Affairs
* Great opportunity to become part of the wholly owned subsidiary of globally
operating Orion Group
* Possibility to utilize your own strengths with the support of the
professionals
* Flexible, high-spirit working setting where your skills are appreciated
* Hybrid Work Policy (In a week - 3 days work from office and flexibility to
work remotely for two times).
* Good work-life balance
* Clear, transparent processes and responsible supervisors are our benefits to
the personnel
At Orion, your work creates true impact and well-being for our customers,
patients and society at large. Our culture of friendliness, respect, mutual
appreciation and diversity creates a safe working environment where you can
strive for excellence. W