Global Regulatory Affairs Manager International
Senior (5-10 ani), Executive (>10 ani)
Regulatory Affairs Manager in Global Regulatory Affairs International- three years contract
What would you do in this role:
Management of Clinical Trial Applications (CTAs), Marketing Authorization (MAlicense maintenance and related activities for the assigned products under the supervision of the Head of Regulatory Affairs.
Be accountable for the regulatory compliance within the area of responsibilities.
How will your main responsibilities will look like:
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.
Preparation of Marketing Authorization (MA) applications, renewals, variations 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.
- 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.
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 minimise delays and any anticipated difficulties.
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 minimise the impact on business.
- Attend relevant meetings across Pfizer providing guidance as necessary to support the development of regulatory activities and strategies.
Technical Skill Requirements:
- In depth knowledge of national/European Union Regulatory and Clinical Trials legislation and guidelines for CTA and MAA.
- Demonstrates keen analytical skills and attention to detail.
- 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).
Your qualifications & Technical Skill Required:
- Life science, medical science, pharmaceutical or chemistry
In depth knowledge of National, EU and ICH directives and regulations.
- ≥ 5 years work experience in Regulatory Affairs or related function within pharmaceutical sector.
- Proven ability to consistently deliver to time, cost and quality standards.