LOOKING FOR REGULATORY LEADER-EXPAT - PHARMA for a Pharma Major
Location - Mauritius
terms @ $100/-hour
QUALIFICATIONS & EXPERIENCE:
Bachelors or Post Graduate degree in Pharmacy /equivalent,6 to 10 years pharmaceutical experience with at least – lat 3 years in leadership roles.Ability to handle multiple projects and bring them to completion in a timely manner,Ability to challenge processes and standards and lead improvement initiatives as well as work with and influence manufacturing and analytical management, to improve standards of,compliance and to meet expectations of quality standards
Excellent written and verbal communication – fluency in English ,
SPECIFIC OUTCOMES / ACCOUNTABILITY:
Regulatory Affairs Co-ordination:
Knowledge of ICH, US, EU and GMP guidelines
Proven experience in handling Marketing Authorization Application in LATAM and European Union (EMEA) and other Asian markets
Proven Experience experience in handling all type of variations.Provide expert advice on appropriate regulatory strategies for product variations
Lead a team of dedicated RA professionals for a project
Review of Dossiers, regulatory documents, response to deficiencies and guide team members.
Responsible for responding to any regulatory queries on behalf of the project team with inputs from other team members.
Ensuring Good Regulatory Practices are followed within the team and also proper training is provided amongst the team members.
Proactively troubleshoots technical/quality issues relating to the preparation and dispatch of submissions.
Liaise with counterpart and applicable line functions for problem solving (ensuring agreed upon action is implemented
Maintenance of the record of post registration technical variation and labeling changes.
Review and approval of Annual product reviews for submitting to Regulatory authorities Internal and external customers are constantly updated as to the progress of their queries;
Grow and foster relationships with the relevant regulatory bodies globally;
Work in close association with regulatory, operations, legal, export commercial and regulatory agents in identified regions
Ensure all licenses are maintained and renewed as required - ensure requisite approvals sought for cancellation;
Ensure executive technical team are kept abreast of all legislative changes in each country.
Ensure launch and supply teams are continuously updated on progress of registrations, MA transfers and variations;
Integrate regulatory and technical aspects into supply chain to ensure continuous supply.
Regulatory Integration with Supply & Operational Teams:
Prioritise regulatory activity based on commercial value to the business;
Ensure all commercial teams have up to date information with regards to registrations due and risks to current registrations, MA transfers and variations;
Ensure launch and supply teams are appraised of activities and manage all issues that can potentially delay launch though problem solving and escalation;
Ensure operational teams have all requisite data required to launch a product and ensure on-going compliance and supply;
Maintenance:
Ensure that relevant change controls are submitted when necessary, in line with current reference IP/dossier;
Responsible for the product regulatory data base available to ensure cohesive repository of Intellectual Property.
Learning & Development
Information is gathered about development needs;
Training and development is negotiated with manager;
Learning solutions are identified, proposed and implemented according to ongoing personal and team development plans;
Best practice is encouraged to ensure expertise. Up-skilling and multi-skilling are co-ordinated in line with staff development
Key Attributes:
Initiative and self starter;
Ability to manage projects in a matrixed team environment and with both internal and external partners;
People management;
Ability to initiate action to correct quality problems or to escalate awareness of quality issues as appropriate;
Vigilance in watching over job processes, tasks and work products to ensure freedom from errors, omissions or defects;
Ability to work in a fast paced international environment, under pressure and to tight deadlines;
Tenacity;
Flexible with working hours;
Able to manage conflict;
Must be detail oriented and have strong prioritization skills;
Willing to travel as and when required.
PLEASE SEND CURRENT RESUME TO remya@mpdgroupmail.com
With thanks &warm regards
REMYA KRISHNAN DIRECT 00919947540009
TEAM LEAD - HR
MPD HRD Division,
OFFICE +91-9847894786/9947540001/484-2838115 /3295930
VISIT US @ http://ping.fm/iXUuM
follow us on www.twitter.com/mpdservices ,http://ping.fm/ImUGK