Regulatory Affairs Specalist CMC

Recruiter
Science Solutions Recruitment
Location
Runcorn
Salary
£25000 - £35000/annum
Posted
13 Jul 2017
Closes
12 Aug 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Science Solutions are currently recruiting a Regulatory Affairs Specialist (CMC) for a generics company. Reporting to the Regulatory Manager (CMC) this position is based in the North West of England.

Key responsibilities:

CMC

* Authoring/editing of regulatory submission documents (Modules 1,2 & 3)
* Ensuring timely preparation and compilation of full Marketing Authorisation Application dossier for assigned projects in accordance with EU and US standards
* Working with CMS document authors from other internal functions and external providers to ensure compliance with regulatory and company guidance/template specifications
* Co-ordination and preparation of responses to Regulatory Agency queries /deficiencies via close cooperation with other involved functions and liaison with Regulatory Agencies where required
* Providing project-specific regulatory strategic advice, technical expertise and coordination oversight for assigned projects
* Directing / mentoring other individuals assigned to support projects, as appropriate
* Participating in project launch meetings, review meetings and project team meetings as required
* Sharing up-to-date legislation and guidance with RA and other colleagues as appropriate
* Building departmental awareness of local regulatory requirements in EU, US and international markets and provide regulatory advice, guidance and support to all project teams, as required
* Archiving registration documentation according to internal processes; introduce regular updates to internal RA database(s)
* Appropriate planning for prioritisation and coordination of activities among functional areas and within Regulatory Affairs, and the identification and communication of project/product related concerns to the relevant departments in a timely manner

Other

* Regulatory assessment of proposed post approval changes
* Assisting in preparation of post approval variation submissions when required
* Develop and maintain systems and procedures to ensure efficient processes and best practice
* Maintenance of site manufacturing authorisations

Knowledge and experience:

* Degree in relevant scientific discipline (or equivalent experience) with 3+ years pharmaceutical industry experience in Regulatory Affairs
* Knowledge of industry trends regarding electronic submissions and experience of eCTD preparation using a publishing tool advantageous
* The successful candidate will have experience authoring, reviewing and editing Marketing Authorisation Applications for EU and US markets.

* Attention to detail and quality of documentation
* Proficiency with MS-Office Suite and Adobe Acrobat applications
* Effective oral and written communication skills in English language
* Self-starter with superior time management skills, and ability to work independently and in teams
* Ability to balance multiple tasks to meet priorities and timelines
* Good judgement and decision-making skills
* Ability to act as liaison with other departments