Company: Pharmalink Consulting
Closing Date: 06 Feb 17
Salary (£): Competitive
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws.
Regulatory CMC Writer - Biopharmaceutical/Vaccine products
Duration: 6 months initial period, further 12-18 month extension
2017 is starting out on a very positive note for Genpact Pharmalink – we are kicking January off with a major new CMC project for one of largest pharmaceutical companies in the world.
We are building the new team across our offices on 3 continents, and our Maidenhead office have immediate vacancies for CMC writers with Biologics experience in the EU markets. The ideal candidates will have around 5 years’ experience in these areas and will be able to hit the ground running, making an instant and tangible contribution to the project team.
Duties will include:
· Providing input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
· Executing regulatory strategies by leading the development, authoring and reviewing of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
· Assessing and communicating potential regulatory risks and proposing mitigation strategies.
As ever, we are searching for regulatory professionals with impeccable communication skills, the ability to diplomatically consult with our clients and advise them of the best path. We are looking for people who have the confidence and experience to challenge current thinking and who can look for alternative, novel ideas to move forward in an ever-changing regulatory world! Our business moves rapidly and we need consultants who are happy to evolve and adjust – you must have flexibility to changing priorities or dealing with unexpected events.
If you would like to join our team and work with some of the brightest minds in the Industry – please get in touch today. We have multiple projects with vacancies available immediately. We are looking forward to hearing from you. Contact Shubha.Prasad@genpact.com today!
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