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Job Details

Regulatory Affairs Manager

Company: SRG Clinical
Location: Runcorn
Reference: J27008
Closing Date: 05 Jul 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

My client is a rapidly expanding Pharmaceutical organisation, who has a vacancy in their Regulatory team. They are actively looking to hire a Regulatory Affairs Manager to their team on a permanent basis in the North West of England.

Requirements:

To oversee the preparation and compilation of MAA’s ensuring all documentation to the highest standard whilst adhering to all compliance guideline.

Major Duties and Responsibilities:

* Oversee all regulatory affairs related project management of Marketing Authorisation Application (MAA) submissions and monitoring status of applications
* Provide cross functional teams with regulatory input in order to obtain timely approvals and contribute to the product development and regulatory strategy planning.
* Authoring of regulatory submission documents (Modules 1,2 and 3)
* Compilation of full initial application dossiers for assigned projects in accordance with EU and US standards, as applicable.
* 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.
* Participating in project launch meetings, review meetings and project team meetings as required. Liaise with CROs to ensure timings and compliance of clinical trials
* Providing project specific regulatory strategic advice, technical expertise and coordination oversight
* Prepare, review and maintain knowledge and understanding of SOPs and assist in the effective implementation of the MAH’s Quality Management System.
* Build business awareness of local regulatory requirements in the EU and international markets and provide regulatory advice, guidance and support to project teams, as required.



Requirements/Qualifications:

* Life Science Degree. Master’s Degree in Pharmacy or other similar Life Science discipline preferred
* Extensive experience within Regulatory Affairs within the pharmaceutical industry, including directly dealing with regulatory agencies.
* Exposure to eCTD format and electronic submission gateways is preferable.
* Experience in the following would be advantageous – Inhalation dosage forms, Generic products, EU MRP/DCP submissions, US NDA/ANDA submissions.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

Apply for this job: Regulatory Affairs Manager

Contact Information:

Address:  Head Office
SRG Clinical 9 Devonshire Square London United Kingdom
EC2M 4HP
England
Tel:  +44 (0)203 096 4700
Website:  Visit Our Web Site

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