23 hours

Manager Approval Liaison

Pfizer
Sandwich, IL 60548
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Purpose



**Breakthroughs that change patients' lives** ... At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.



Digital Transformation Strategy



One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.



**JOB SUMMARY**



The purpose of this position is to:



+ Create and deliver strategic regulatory guidance for assigned projects/products. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines

+ Develop and implement Regulatory Strategies for assigned projects/products including assurance that project prioritization, submission strategies, labeling, approvals, post-marketing lifecycle management/maintenance activities, etc., are in place and delivered in accordance with time, cost and quality expectations for all assigned projects.

+ Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.

+ Direct and/or indirect liaison with regulatory authorities to facilitate the prompt review and approval of applications, variations, and commitment closures.

+ Lead and/or participates in Regulatory Teams for assigned projects/products..

+ Understand regulatory environment and communicates priorities to global stakeholders.

+ Deliver project /product strategy incl. label, risk assessment, and probability of regulatory success for assigned projects/products.



**JOB RESPONSIBILITIES**



The major duties and responsibilities will include but are not limited to:



+ Accountable for ensuring or contributing to Global/Regional Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.

+ Ensures regulatory contributions achieve strategic objectives and agreed standards, while minimizing resource demands and maximizing overall project delivery time.

+ Partners with project teams and other customer groups (e.g., Country Regulatory Managers, Brand Teams, PGS, etc.) to ensure required regulatory contributions (e.g. responses to regulatory queries, briefing documents, strategy plans etc.,) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.

+ Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.

+ Ensures an aligned regulatory position is reached, communicated and championed for all key issues for assigned project/s.

+ Works closely with other Regulatory and CMC Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learning's and quality standards.

+ Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.

+ Engages in appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.

+ Ensures business compliance and implementation of and adherence to Regulatory standards.

+ Develops and maintains constructive working relationship with Health Authority contacts.



**QUALIFICATIONS / SKILLS**



+ Regulatory Knowledge: Knowledge of the regulatory environment and how this impacts regulatory strategy and implementation. Understanding of regulatory agency philosophy and guidelines.

+ Experience preparing and submitting MAAs, line extensions, post-marketing submission in the EU; experience in other regions may be helpful.

+ Working with and influencing, opinion leaders, external organizations facilitating approval of submissions.

+ Commercial Awareness: Demonstrated knowledge of global regulatory procedures and requirements.

+ Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting MAAs and post approval variations.

+ Problem Solving and Analysis: Strong problem identification, analytical and solving skills.

+ Communication skills: Communicates effectively using a variety of mediums appropriate to the setting.

+ Negotiation skills: Gains trust quickly of other parties to the negotiations and can negotiate skillfully in tough situations with both internal and external groups.

+ Can be direct and forceful as well as diplomatic.

+ B.S. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.

+ Proven examples of delivery across in the post-licensing environment with demonstrable contribution in Regulatory Affairs.

+ Proven ability to manage complex regulatory issues.

+ Proven ability to consistently deliver to time, cost and quality standards.



**ORGANIZATIONAL RELATIONSHIPS**



+ Reports to Brands Cluster Lead

+ Works with internal GRA groups and relevant project teams. In addition works with relevant development/commercial team representatives within the PGS, and GPD (Worldwide Safety, Global Medical, Global Clinical, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal).



Flexibility



We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.Let's start the conversation!



Equal Employment Opportunity



We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.



\#LI-PFE



Purpose



**Breakthroughs that change patients' lives** ... At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.



Digital Transformation Strategy



One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.



Flexibility



We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.Let's start the conversation!



Equal Employment Opportunity



We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.



Regulatory Affairs
Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Manager Approval Liaison

Pfizer
Sandwich, IL 60548

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