Senior Regulatory Affairs Associate, Global – Oxford – Permanent
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Senior Regulatory Affairs Associate, Global.
Based in Oxford, the Senior Associate for global expansion ROW, will focus on the life-cycle maintenance activities associated with maintaining multiple marketing authorisations in the LATAM, MENA and ASIA-PAC regions. The individual will be responsible for liaising and collaborating with in-country partners and consultants to ensure the compliance of the MA’s. The Senior Associate will be responsible for comprehensive tracking of submissions and approvals and ensuring that the document management systems are accurately maintained. He/she will support 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.
This position will work closely with Regulatory Affairs colleagues and interact cross-functionally with members of the Clinical, Medical, Legal, Safety, Commercial, Quality and Supply Chain organizations.
Required Knowledge, Skills, and Abilities:
- 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) preferred.
- Experience in licence maintenance activities (EU or ROW territories) with demonstrable experience of submissions of e.g. variations, renewals, PSUR’s etc.
- Excellent written and verbal communication skills.
- Good attention to detail and experience in tracking associated with good IT skills and database input.
- Ability to review regulatory documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
- Ability to establish and meet timelines for regulatory submissions.
- Must be able to work successfully within a team / partnership environment and as an individual contributor, with a high level of professionalism.
- Ability to interact effectively with all levels / roles of project team members.
- Ability to travel occasionally – approximately <10% regional and / or international travel.
- Responsibilities may require working outside of “normal” hours, in order to meet business demands.
Required / Preferred Education and Licenses:
- Bachelor’s degree required (Scientific discipline preferred) (or equivalent industry-related experience).
To be considered for this position please apply below.