Regulatory Affairs Manager

Global Regulatory Affairs – International

Position Purpose:

Management of Clinical Trial Applications (CTAs), Marketing Authorization (MA),  license 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.

 Primary Responsibilities:

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.

 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.

  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.

 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).

 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.

 Strategic role:

• Develop and enhance working relationships with Regulatory Authorities and trade associations.
• Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues.
• 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.
• 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.

 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.

 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.
• 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).

Qualifications (., preferred education, experience, attributes):

Regulatory Affairs Manager

Education

• Life science, medical science, pharmaceutical or chemistry graduate. 

Experience

• 6 years work experience in Regulatory Affairs or related function within pharmaceutical sector.
• Extensive experience in regulatory affairs, preferably in human medicines. Proven ability to manage complex regulatory issues.
• Demonstrable experience across the Drug, Discovery, Development and commercialization life cycle, with proven examples of contribution.
• Proven ability to consistently deliver to time, cost and quality standards.
• General management experience and previous line management experience is essential.
• Demonstrable experience of effective delivery in a complex matrix environment.
• Strong management skills, including talent development, team working, problem solving, communication and interpersonal skills.
• In depth knowledge of national/EU regulatory legislation and guidelines as well as Clinical Trials.
• Understanding of business and financial environment, drug development process and the pharmaceutical industry.
• Knowledge and understanding of quality systems, processes, audit and inspections.
• Ability to influence at all levels in the organization and build networks internal and externally.