Assistant Manager, Regulatory Sciences (Evergreen Position)

Job Description

The person will be responsible for overseeing strategy relating to obtaining, managing and maintaining product Marketing Authorization’s and support Clinical Trial Authorization’s (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs. Under the guidance and supervision of line management, lead 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 and support line management to make decisions that require developing innovative solutions to resolve complex problems.

Job Responsibilities

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 for Oncology portfolio for India, all TAs for Indochina and non-vaccine portfolio for Brunei.

· 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, 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 strategists to provide country input into Global and Regional regulatory strategies as required.

Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests :

· Use expert knowledge of national legislation, guidelines and regulatory environment to provide insightful responses to enquiries from cross-divisional Pfizer colleagues and indirect interactions with external customers.

· Advise on matters of compliance, national 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 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.

· Utilize 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 is 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 to obtain a better outcome for the business/patients.

Clinical Trials :

· Support the following strategic clinical development activities in partnership with national Regulatory Authorities, Above Country Regulatory Strategists and Clinical Trials Regulatory Strategy Execution (CTRSE) as applicable:

· Optimization of Clinical Development Plan (CDP) and Country Footprint.

· Communications with NRAs to clarify questions during assessment as required by CTRSE

· Support Regulatory Requirements Manager (RRM) updates for local Clinical Trial Applications (CTAs) and study conduct requirements.

· Participation in national CTA Trade Association working groups and advocacy activities.

Populate and Maintain Regulatory Databases: · Perform database entry and the document management for regulatory transactions undertaken by Country Regulatory 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 in the Management of 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.

Devices :

• •Support regulatory activities for the development and maintenance of medical devices if required.
• •undefined 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, guiding more junior colleagues in relation to best practice and required procedures.Through maintenance of regulatory activities in line with company procedures for own products, contribute to “inspection ready” state. Support Regulatory Group Development : · Contribute to and support as necessary, the maintenance and development of the cluster/country Regulatory team through pro-active involvement and participation and in some instances, leading of special projects; e.g. development of new operating procedures.· Support drive towards Pfizer and GRS Vision and Values.Support development of regulatory colleagues by sharing relevant knowledge and experience. Lead Personal Development and support coaching/mentoring of team members : 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 any development areas. Act as a senior mentor/coach for less experienced colleagues. Regulatory Team Support : Oversee any assigned contractors to achieve agreed objectives, with high quality outputs, and to identify and address training and development needs. Ensure any assigned contractors are supported and that they have a manageable