JOB SUMMARY
Accountable for all strategic regulatory activities for the country including pre- and post-authorization product lifecycle activities for the assigned portfolio and delivery of operational regulatory activities in partnership with above-country operational hubs.
Deliver country strategic priorities and operational plans to budget. Provide regulatory guidance/input into global and regional product development and regulatory strategies.
Application to MoH for new products & current MAs and following up the process for the assigned products with more focused regulatory approach to supporting country business objectives.
Accountable for effective relationships and representing the company with the local Regulatory Authority
JOB RESPONSIBILITIES
- Strong contribution to the regulatory strategies and also perform registration of new products and line extensions, and their lifecycle management; submissions, approvals and maintaining of GMP certificates.
- Provides input into global and regional development and regulatory strategies to provide optimal support for meeting country business objectives and culture.
- Ensures that all regulatory activities in the country are managed in compliance with Pfizer standards and international/local regulations;
- Following up the new product registration process and coordination with legal division in order to protect intellectual property rights and data exclusivity.
- Continuous communication with MoH, official institutions, commitees and associations.
- Filing and storage of all registration relevant documents in the appropriate folders as determined in relevant SOPs.
- Preparation of the New Drug Application (NDA) and ensuring that all required documentation in compliance with MoH regulations is generated, collected, delivered and filed during the registration process.
- Follow up of the registration process through MoH and related Opinion Leaders.
- Global and local databases up to date always as stated in the SOPs.
- Notifying global regulatory with SME roles.
- Develop & plan regulatory strategy for new products & current MAs in cooperation with global and related departments at PCO.
- Prepare GMP dossiers, follow up GMP procedures before- throughout & after inspections.
- Follow up the guidelines and make necessary correspondence with authorities.
- Follow up all correspondences with BoH to get approvals.
- Attend to the GMP inspections as a Pfizer representative.
- Follow-up of outstanding applications and queries with business focus.
- Communication with Authorities on Product Registration issues as required
- Respond to spontaneous requests from authorities promptly and accurately ensuring that all relevant in house liaison has taken place to avoid misinformation or communication breakdown.
- Develop strong partnerships within the country (e.g. Country Managers, Medical, Marketing, Supply Chain), and above-country functions (e.g. GCMC, WSR Regulatory Hubs) and above-country WSR Therapeutic Area and Regional Teams to facilitate the development and implementation of regulatory strategies to expedite the registration of new products, line extensions and life-cycle optimization.
- Regulatory positions on policy topics for communication to in-country internal and external stakeholders.
- Ensure internal regulatory processes and procedures are well documented and support compliant regulatory activities.
- Assure local licenses in country under responsibility are maintained (e.g. Marketing Authorizations) in compliance with local regulations and following corporate policies, regulatory processes, SOPs and keeping the systems updated (e.g. Product labelling, etc.)
- Responsible for developing and enhancing relationships with key external entities (HA’s/BoH, RKOL’s, etc.). Manage the HA/BoH interface throughout the product development and product lifecycle, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership. Represents the Company at the local Regulatory Authority(ies).
- Partner with Regulatory Policy to develop and reinforce Pfizer regulatory positions with external stakeholders and understanding of the external environment.
- Understand local regulations and developing trends in the local regulatory environment of the country under responsibility and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making. Influence on new legislation initiatives that could impact the business.
QUALIFICATIONS / SKILLS
- Scientific degree from Pharmacy, Biology, Chemistry or Chemical Engineering departments
- Appropriate regulatory experience min 2 years
- Proven ability to manage complex regulatory issues.
- Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution
- Proven ability to consistently deliver to time, cost and quality standards
- Demonstrable experience of effective delivery in a complex matrix environment.
- Have a good command of written and spoken English
- Have good communication-influencing skills.
• Years of Experience
2 - 5 years of experience
• Level of Education
Bachelor’s(Graduate), Master’s(Graduate), Doctorate(Graduate)
