The Position
Summary
The role provides leadership to areas of responsibility on complex regulatory affairs activities including regulatory submissions and labeling and to provide support on any regulatory affairs matters required for commercial operations.
Is responsible to lead regional regulation review process, providing guidance to the organization with respect to health authority expectations and requirements; preparing, submitting and negotiating with global and regional regulatory bodies to obtain approval or clearance of premarket registration as well as post market compliance.
The below job description is not intended to be exhaustive, additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.
Your Responsibilities
- Monitor, assess and influence the regional regulatory landscape, establish, develop and execute regional submissions strategy and ensure compliant implementation into regional processes and communication to global functions and regional business. Provides expertise in translating regulatory requirements into practice, workable plans.
- Takes a lead role in communications and establishes strategic advocacy program for ensuring reasonable domestic and international standards that minimize barriers to market entry of new products, programs and services.
- To establish and maintain contact with regulatory authorities, engaging with and influence regional regulatory authorities to guarantee the establishment of an adequate regulatory environment for products to facilitate business growth
- To drive regulatory focus within the region with the team of regional regulatory responsible. Ensuring communication, disseminating relevant information to key stakeholders Building capacity across the organisation for regulatory topics using community forums, emails and face to face meetings.
- Educates internal and external customers regarding submissions issues regarding products. Acts as subject matter expert to senior management and project teams on critical regulatory issues.
- May serve as a contact with affiliates to achieve regulatory compliance
- Assures timely regulatory clearances and registrations for new product launches, renewals to ensure timely market access, continuous product availability and compliance.
- To collaborate with the Product Quality and Safety lead regarding the requirements for Adverse event reporting and recall management ensuring compliance to regional regulations
- Aligning with key cross-functional partners within the organisation at various levels involving matters between functional areas, other departments or org units, or customers and the company (eg Marketing, Product Management, Supply Chain)
- To actively support local organizations and marketing, sales and logistic departments to obtain documents related with regulatory affairs such as certificates, declarations, etc., needed ad required for tender processes, contracts and /or any commercial activity
- Represent the company in all the Regulatory Audit/Inspection visits, maintain all records for Audit/ Inspection visits as per Corporate Records Management and follow up all the required corrective actions through progress sheets.
- Check/approve promotional materials as routed through internal tools for compliance to promotional practice regulations.
Compliance
You are expected to adhere through your conduct to all applicable laws and regulations as well as to the high integrity standards as set forth by Roche.
Who You Are
- You hold a University degree in Medical, Biomedical, Biochemistry, Biotechnology or relevant scientific education. Post graduate/MSc degree and/or Qualified Pharmacist will be preferred
- You have at least 7 to 10 years in Regulatory Affairs, Regulatory Compliance, with significant depth of experience within the medical device industry
- You have at least 5 years of experience in leading people and organizations, and are able to independently drive impact-full initiatives/projects from start to finish
- You have proven knowledge with Regulations of FDA, CE, ISO laboratory and manufacturer requirements
- You are experienced in dealing with senior business leaders, business units and regulatory authorities
- You are able to work both independently and in a team environment, are very collaborative, and are able to build and maintain a network both internally and externally
- You have a strategic mind-set and are able to priorities and keep a holistic view on things
- You are a strong negotiator and are able to communicate clearly and professionally both verbally and in writing
- You are fluent in English both verbally and in writing. Arabic is a plus, or any spoken language in the market
- You are proactive, a self-starter, and are creative
- You are flexible and willing to travel within the region when required
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
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