Manager, Regulatory Strategy
- Experience Level
Manager of Regulatory Strategy
PRA and our employees have won numerous awards and accolades in the CRO industry and 2020 hasn’t been any different with gold winners in the Project Manager and Clinical Research Team of the Year at the Pharma Times awards! We have won multiple awards across Europe, The America’s and Asia Pacific including BioPharma Asia/Phar-East Best CRO, Pharma Times Clinical Company of The Year and special recognition at the Vaccine Industry Excellent Awards
As a Manager of Regulatory Strategy, you will be dedicated to one of our pharmaceutical clients with a truly global presence; this unique industry-changing partnership redefines collaboration. The program is ideal for individuals who thrive in a continually-evolving culture that mirrors PRA’s commitment to career development.
The Manager of Regulatory Strategy is aligned to the client’s portfolio of licensed products. The manager is responsible for the RA activities of assigned products in Emerging Markets working in collaboration with the client’s global functions and affiliate companies and partners across EM.
Providing EM strategic and functional input to the global team, the Manager of Regulatory Strategy will plan, manage and execute regulatory activities on licensed products.
Other responsibilities will include:
- Responsible for EMRA strategic input for assigned products throughout its lifecycle
- Submission of variations, renewals, line extensions, responses to requests for further information and marketing authorisation applications in additional EM countries
- Interfaces cross-functionally within RA, as well as with Commercial, Clinical Development, Global Marketing, etc. to identify what EMRA requirements will impact the global strategy and how to best move forward to meet project plans
- Communicate with Regulatory Authorities to facilitate productive dialogue on assigned products
- Liaise with external companies with respect out-licensing supporting activities as required
- Handling of regulatory documents in the electronic document management system
- Regulatory assessment of change requests
A team worker with the ability to influence in order to achieve objectives. You will have excellent organisational skills, flexibility and attention to detail along with a mind-set towards adherence to timelines.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- A degree in pharmacy/life sciences or similar
- Direct experience in emerging markets Regulatory Affairs
- Proven experience of making new marketing authorisation applications and post-marketing activities in EM
- Some experience of interactions with Regulatory Authorities
- Proven ability to provide strategic regulatory guidance for registration and post-marketing activities
- Demonstratable leadership skills and strong problem-solving abilities, negotiation and communication skills
- The ability to work independently and function well in a team-orientated environment
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.