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 significant role in the
area of Regulatory Affairs
Excellent prospect 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