Regulatory Affairs Associate

Recruiter
KELLY SERVICES LIMITED
Location
Cambridge
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Kelly Scientific are working with a leading life sciences organisation who are looking for a Regulatory Affairs Associate to join on a 12 month contract which has the potential to be extended.

The successful candidate will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

Further Responsibilities:

- Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)

-Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead

-Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications

-Review regional component of the Global Regulatory Plan and provide input to operational deliverables

-Ensure compliance via timely submissions to regulatory agencies

-Collaborate with CRO's / partners to support site initiation

-Coordinate collection of functional documents in support of regulatory applications

-As appropriate, support execution of regulatory strategy

-Coordinate QC of regulatory documentation (e.g. briefing packages)

-Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)

- Prepare regulatory packages and cross-reference letters to support investigator initiated studies

Requirements:

- Life Sciences degree essential

- Proven regulatory knowledge (2 years+) especially CMC for worldwide submissions is required for this role

- Experience of document management systems is highly advantageous

-Strong communication skills - oral and written

-Understanding of drug development process