Regulatory Affairs Specialist
Middle (2-5 years), Senior (5-10 years), Executive (>10 years)
For one of our clients, Pfizer - one of the world’s largest research-based pharmaceutical and biomedical companies, dedicated to discovering, developing, manufacturing, and marketing prescription medications for both humans and animals, we are currently recruiting a Regulatory Affairs Specialist.
- Life science, medical science, pharmaceutical or chemistry graduate.
- ≥ 2 years work experience in Regulatory Affairs or related function within pharmaceutical sector.
- Proven ability to consistently deliver to time, cost and quality standards.
- In depth knowledge of National, EU and ICH directives and regulations.
- Experience in Clinical Trial Applications is not mandatory but would be an asset.
- In depth knowledge of national/European Union Regulatory legislation for Marketing Authorization Applications;
- In depth knowledge of national/European Union Regulatory legislation for Clinical Trials and guidelines for CTA;
- Demonstrates keen analytical skills and attention to details;
- Able to work in a fast-paced environment with competing priorities;
- Ability to work independently as well as part of a team;
- Strong project management skills, problem solving, communication and interpersonal skills;
- Demonstrates effective relationship management and customer orientation;
- High level of proficiency in both local language and English (written and spoken);
- Very good verbal and written communication skills;
- Ability to interpret and relay technical information;
- Very good time management;
- Proficiency with computer and software applications (MS Office, MS Windows, etc).
1. Preparation of Marketing Authorization (MA) applications, Renewals, Variations to the MA and related activities:
- Collate, coordinate and, where required, create the necessary technical data to support the submission of new MA applications, renewals and variations for the assigned products in accordance with the local legislation, ensuring that their presentation and the contents comply with the required format;
- Support the European wide application process for the assigned products, clarifying the requirements and ensuring local needs are met;
- Inform the relevant internal stakeholders, according to global and local policies and procedures, about the regulatory authority’s approval of changes to the packaging component(s) for the assigned products to ensure their timely and accurate implementation;
- Link with the Product Quality Manager for timely implementation of the approved labelling-associated artworks.
2. Management of Clinical Trial Applications (CTAs) Regulatory activities:
- Liaise with clinical research project managers to seek to understand clinical research programme;
- In partnership with above-country operational hubs, above-country WSR strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority (RA) queries;
- Interaction with Local RA for CTAs;
- Ensure timely communication of any GCP breaches, or actions taken for safety reasons;
- Accountable for the regulatory compliance within CTA responsibilities.
3. Tracking Databases
- Handling with all relevant global databases and systems and other applications, as appropriate;
- Keep updated the local registration tracking of all new/ongoing applications, renewals and variations for the assigned products, and corresponding related databases/systems.
4. Follow-up of outstanding applications and queries with business focus
- Monitor the progress of applications against the set timelines, taking action when necessary (taking account of application) to minimize delays and any anticipated difficulties.
5. Interaction with internal stakeholders
- Provide accurate, consistent, timely and balanced responses to the Regulatory inquiries on the assigned products raised by relevant internal stakeholders;
- Upon request of the local Product Quality Manager, play an active role in product quality issues actions in order to minimize the impact on business;
- Attend relevant meetings across Pfizer providing guidance as necessary to support the development of regulatory activities and strategies.
6. Handling Regulatory Inquiries (external stakeholders, non-authority)
- Provide accurate, consistent, timely and balanced responses to the Regulatory inquiries for the assigned products raised by external stakeholders, non-authority (. through the Medical Information).
7. Quality Assurance
- Acquire quality processes and procedures knowledge;
- Demonstrate value proposition of quality and compliance to internal and external stakeholders;
- Apply a risk management approach.
8. Inspections / Audits
- Provide support for all audits under Medical Director / Platform Head (Regulatory/Safety) Accountability, including audit corrective and preventive action plans (CAPAs);
- Audit preparedness.
9. Strategic role:
- Develop and enhance working relationships with Regulatory Authorities;
- Respond to spontaneous requests from authorities promptly and accurately;
- Work with authorities if Pfizer position differs from authority position in order to obtain a better outcome for the business/patients;
- Utilize local knowledge of Regulatory Authority’s expectations, ways of working etc. to appropriately direct company strategy. Share updates with colleagues;
- Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
10. Self Development
- Define individual objectives in alignment with company objectives;
- Implement individual development plan (IDP) within current role, in accordance with the training curricula;
- Active participation in Pfizer training programs and international meetings as per IDP;
- Maintain awareness/knowledge of the current legislation.
The employment contract is full-time and on determined period of time, until the 31st of May, 2021.