Resourcing Life Science
Line Manager / Regulatory Affairs Manager Germany
Resourcing Life Science, New Bremen, Ohio, United States
What to Expect
Line management, training of Regulatory Specialist
Training of the direct reports in EMEA / FDA requirements
Establish and manage regulatory submission timelines for both new and existing products across key global markets
Engage with regulatory authorities and distribution partners to support product registrations
Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
Act as the regulatory representative on cross‑functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance
Support and participate in inspections and audits conducted by global regulatory authorities.
Requirements
Min 8 years in regulatory affairs
Min 4 years as Regulatory Affairs Manager
Experience with EMEA / FDA regulatory requirements
Ideally line management of a team
Excellent written and verbal in English
Availability to work 4 days in the office
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk
#J-18808-Ljbffr
Line management, training of Regulatory Specialist
Training of the direct reports in EMEA / FDA requirements
Establish and manage regulatory submission timelines for both new and existing products across key global markets
Engage with regulatory authorities and distribution partners to support product registrations
Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
Act as the regulatory representative on cross‑functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance
Support and participate in inspections and audits conducted by global regulatory authorities.
Requirements
Min 8 years in regulatory affairs
Min 4 years as Regulatory Affairs Manager
Experience with EMEA / FDA regulatory requirements
Ideally line management of a team
Excellent written and verbal in English
Availability to work 4 days in the office
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk
#J-18808-Ljbffr