Regulatory Senior Associate - Emerging Markets
A global and innovative biopharmaceutical company is currently recruiting a Regulatory Senior Associate, Emerging Markets. The company employs more than 1,500 experts, analysts, specialists, advocates, scientists and professionals across 13 offices and nearly 20 countries. This is an exciting opportunity to bring expertise and skills to a leading organisation that specialises in sleep medicine and with a growing presence in hematology/oncology.
- Focussing on the life-cycle maintenance activities associated with maintaining multiple marketing authorisations in the LATAM, MENA and ASIA-PAC regions.
- Liaising and collaborating with in-country partners and consultants to ensure the compliance of the MA's.
- Comprehensive tracking of submissions and approvals and ensuring that the company document management systems are accurately maintained.
- Supporting the Senior Manager/Senior Director in new MAA filings in the ROW territories and as experience develops it is anticipated that the Senior Associate becomes involved in leading submission teams in MAA filings.
- Working closely with Regulatory Affairs colleagues and interact cross-functionally with members of the Clinical, Medical, Legal, Safety, Commercial, Quality and Supply Chain organisations.
Skills and Requirements:
- Minimum of 2 years of increasingly responsible experience in the pharmaceutical industry, including at least 1 year of direct experience in licence maintenance/or 1 year of experience in other regulatory affairs function(s).
- Experience in licence maintenance activities (EU or ROW territories) with demonstrable experience of submissions of e.g. variations, renewals, PSUR's etc.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at 0203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.