Regulatory Affairs Senior Manager
- Employer
- Planet Pharma Staffing Limited
- Location
- Cambridge, Cambridgeshire (GB) or Uxbridge, London
- Salary
- Competitive salary
- Start date
- 28 Jul 2019
- Closing date
- 27 Aug 2019
View more
- Discipline
- Clinical Research, Regulatory Affairs, CMC, Compliance, Labelling, Regulatory Writing
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Senior Management
Job Details
Client: Pharma
Type: Contract
Duration: 12 months
Start: ASAP
Company summary
In this role, you will be working with one of the global leading pharmaceutical company. This company is known as one of the best places to work for, as they empower their staff to build their own career paths by providing reward schemes for their contributions and future potential with opportunities that match their unique talents. They also provide competitive salary package and flexible working hours.
Responsibilities
- As a manager, you will be ensuring regulatory compliance, with a focus on patient safety.
- Accountable for executing the approved regional strategy for assigned programs and representing the region.
- Liable for advising the GRT on regional considerations in forming a strategy. You will design and plan product-related regulatory strategies and regulatory Affairs processes according to national legislation and regulatory requirements.
- Assuring the regional necessities are fully established and executed in collaboration with relevant regional stakeholders.
- You will be assessing and reporting the influence of relevant regional regulations, guidance, current regulatory environment and competitor labelling.
- Responsible for Health Authority Interactions.
- Maintaining regulatory submissions (e.g. clinical trial and marketing applications) for products within the company's portfolio in compliance with global filing plans and local regulatory requirements.
- Assembles and oversees Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
Requirements
- You will be required to have 10+ years of experience in Regulatory affair within Pharmaceutical companies
- Has experience in early development and safety of clinical trials.
- Remit EU and CH
- Team Player
- Attention to detail
To apply please contact Sophiya Pun on +44 (0) 203 928 8387
Company
Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.
Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.
We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.
Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.
- Website
- http://www.planet-pharma.co.uk/
- Telephone
- +44 203 868 1000
- Location
-
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom
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