Reg Affairs Senior Manager, Emerging Mkts
Oliver Care is recruiting for a Regulatory Affairs Senior Manager, Emerging Markets to join a company in the pharmaceutical industry at their site based in the South East on a contract basis.
The main purpose of your role as Regulatory Affairs Senior Manager, Emerging Markets will be to:
- Provide expertise on regional regulatory requirements in emerging markets, develop and maintain the regulatory knowledge management tool and interface with Global teams and regional hubs.
- Coordinate and manage intelligence activities in emerging markets including leading the intelligence management process, leading creation of the company's position on new requirements and communicating new emerging markets intelligence proactively to all stakeholders.
- Monitor and assess the impact of global regulations, guidance's and current regulatory environment, apply these to the job and educate stakeholders.
Further responsibilities will include:
- Monitoring external regulatory environment for new developments, developing and maintaining templates for regional requirements and conducting regular RTQ trend analysis to ascertain areas of focus for authorities that may need to be implemented in submissions.
- May participate in cross-functional teams and contribute to the regional teams (APAC, LATAM and EEMEA).
- May be responsible for training staff on select intelligence management procedures and systems and provide intelligence support to company emerging market representatives on association work groups.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or higher in life sciences/engineering or related field with in-depth experience of pharma/biotech/medical device industries and a broad knowledge of Regulatory Affairs.
- Specific regulatory knowledge and experience of emerging markets and direct experience with MAAs or variations and creation and execution of regulatory strategies. Direct experience of management of intelligence.
- Strong negotiation and project management skills and the ability to work well with others in demanding situations.
For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL29829 in all correspondence.