Work Location Assignment: Mexico City, Mexico. Must be able to work from assigned Pfizer office 3 days per week, or as needed by the business.
JOB SUMMARY
Lead, manage and provide strategic direction to their regulatory team in assigned markets.
Manage assigned projects at a cluster level; provide strategic regulatory input into cross-functional product teams for pre- and post-authorisation product lifecycle activities working with above country operational hubs on operational activities.
Oversee strategy related to obtaining, managing and maintaining product Marketing Authorisations and support Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs. Conduct associated strategic regulatory activities for assigned products and markets and contribute to the implementation and leadership of projects and building expertise within the cluster regulatory team.
JOB RESPONSIBILITIES
Cluster & Project Management
- Responsible for identifying, implementing and managing key regulatory cluster/country projects either on an individual basis or as part of the Cluster leadership Team, to meet cluster regulatory objectives, including agreeing priorities with Head of Regulatory Sciences for the cluster/country as appropriate.
- Leading role implementing effective and efficient processes in the cluster/country.
- Monitor regulatory activities across product therapy areas and assist with the management of projects as necessary to ensure compliance with regulatory authority and corporate requirements and timelines.
- Deputise for Head of Regulatory Sciences for the cluster/country as required.
People and Resource Management
- Manage performance of direct reports to achieve agreed objectives, with high quality outputs, and to identify and address training and development needs.
- Ensure regulatory team members work effectively in a productive and well-motivated environment through providing ongoing coaching, guidance and sharing of regulatory expertise.
- Ensure direct reports are supported and that direct reports have a manageable workload through redistribution, prioritisation or outsourcing of work, as necessary including planning of appropriate timelines and resource allocation. Include consideration of individual strengths when allocated project/product responsibilities.
- Participate in the recruitment of new staff as required.
- Ensures that all regulatory activities in the team are managed in compliance with Pfizer standards and international/local regulations.
Deliver Regulatory Strategy and Advise Cross-Functional Teams
- In line with assigned product and country responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
- Represent Regulatory on cross-functional product teams and provide strategic regulatory input to the commercial operating planning process.
- Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate, including
- ensuring teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.
- Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.
- Work with above country regulatory strategists to provide country specific input into Global and Regional regulatory strategies as required.
- Ensure alignment of local and regional regulatory strategy and tactics.
Provide Regulatory Advice and Information to meet Customer and cross-divisional colleague requests.
- Use expert knowledge of national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers.
- Advise on matters of compliance, regulatory requirements and Pfizer regulatory policy.
- Use a variety of communication tools and techniques to present complex ideas.
- Anticipate potential objections and influence others.
Manage New Registration/Marketing Authorization Applications:
National Applications
- Coordinate pre-submission meetings and other National Regulatory Authority (NRA) engagements, such as EU national Scientific Advice Meetings.
- Devise and obtain endorsement for submission strategy and plan and partner with above-country operational hubs and above-country strategists to obtain new product licenses. Manage associated interactions and negotiations with NRAs.
Manage Marketing Authorisation (MA) Variation Applications
- Trigger locally driven submission demands (e.g. NRA queries and requests for local label updates).
- Input to assessing regulatory impact, agree filing strategy with other business functions as appropriate and participate in risk-based reviews with above-country hubs and communicate any locally triggered delays & risks impacting the submission/approval, to the above and in-country stakeholders.
- Work with above-country strategists and above-country operational hubs to supply country documentation/information for dossier build as applicable.
- Communicate NRA decisions to relevant internal stakeholders as applicable.
Manage MA Renewal Applications
- Agree filing strategy with relevant stakeholders as appropriate and participate in risk-based reviews of plans with above country hubs.
Management of NRA queries
- In partnership with above-country operational hubs and above-country strategists, respond to NRA queries.
External Relationships
- Proactively take opportunities to develop or 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.
- Utilise local knowledge of NRA’s expectations, ways of working etc to appropriately direct company strategy. Share updates and regulatory intelligence 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.
- Populate and Maintain Regulatory Databases
- Perform database entry and the document management for regulatory transactions undertaken by Country Strategists, in line with global SOPs.
Obtain NRA Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)
- Following a request from a prescriber and internal approval to proceed with supply of unlicensed Pfizer medicines to address unmet patient needs, facilitate NRA approval for supply/import via above country execution hub.
Safeguard Compliance and Manage Packaging and Prescribing Information Component updates
- Via defined procedures notify relevant internal stakeholders of NRA approval of changes to packaging components and prescribing information and the timelines for associated implementation activities.
- Negotiate extensions to packaging artwork implementation with Regulatory Authorities when applicable.
Support MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity
Working with local stakeholders and above country operational Hubs, where applicable:
Divestments: Advise business on regulatory activities required prior to divestment/transfer of licence. Support licence transfer.
Discontinuations: Liaise with local Commercial/Medical/Demand functions and advise on regulatory action required for discontinuation of a product in the country marketplace.
Upon receipt of above-county endorsement to proceed, trigger applicable notification to NRA and other external stakeholders as required by national regulations.
Cancellations: Upon receipt of in and above-county endorsement to proceed, manage applicable notification/request to NRA, as required by national regulations. Notify relevant colleagues of approval of the licence cancellation.
Interruptions to Supply: Notify NRAs of interruptions to supply in accord with national regulations and as agreed with cross functional team.
Work with cross functional team to explore options to help minimise or mitigate the out of stock. Obtain the necessary NRA approval as required and partner with above-country Operational Hubs as applicable.
Support Third Party Licences
- Manage relevant, local regulatory activities related to supporting third party licences for which Pfizer has a contractual obligation, in accord with applicable business agreements and Pfizer SOPs.
Devices
- Support regulatory activities for the development and maintenance of medical if required.
- Contribute to Good Regulatory Practice (GRP)
- Adhere to relevant procedures and practices (SOPs, Job Aids and WIs) to ensure GRP is maintained.
- Help identify changes to business processes to improve them as necessary, including to reflect changes in regulations.
- Lead by example in relation to best practice and required procedures.
- Through maintenance of regulatory activities in line with company procedures, contribute to “inspection ready” state.
Lead Personal & Team Development
- Identify own training and development needs in discussion with Manager to ensure a broadening skill and knowledge base and to maximise/optimise career development and contribution to the business.
- Develop product and therapeutic area knowledge as needed, according to product responsibilities list.
- With support of Manager build on competency strengths and address development areas
- Support personal development plans for direct reports.
QUALIFICATIONS / SKILLS
· Life sciences or chemistry graduate to honours level or equivalent
· Masters Degree, Post Graduate Diploma or PhD preferred
· Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory)
· Previous experience and proven track record in Regulatory (Human Medicinal Products)
· Previous experience and demonstrated line management capability and/or experience of coaching and mentoring
· Computer literacy
· Excellent written and verbal communication skills, Fluency in English/Spanish required
· Proven strength in analytical thinking
· Leadership capability
ORGANIZATIONAL RELATIONSHIPS
External:
Federal Commission for the protection against sanitary risk (COFEPRIS)
National Agency for Regulation Control and Health Surveillance (ARCSA)
In Mexico CANIFARMA and AMIIF
In Ecuador IFI
Internal:
Commercial
Medical
Access and Value
Quality
Regulatory Law
Regulatory International Operations
Global CMC
GILA
PGS
Global and International Regulatory Policy
Legal
Finance
EEO (Equal Employment Opportunity) & Employment Eligibility
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Regulatory Affairs