Regulatory Strategist Manager Job at Pfizer
Pfizer - Good health is vital to all of us, and finding sustainable
solutions to the most pressing health care challenges of our world
cannot wait. That's why we at Pfizer are committed to applying science
and our global resources to improve health and well-being at every
stage of life. We strive to provide access to safe, effective and
affordable medicines and related health care services to the people who
need them.
We are recruiting to fill the position of:
Job Title: Manager, Regulatory Strategist
Job ID: 1030874
Location: Nigeria
Role Description
The purpose of this role is to:
- Create and deliver strategic regulatory guidance for assigned
projects/products, with an appropriate level of supervision. Strategies
should be in alignment with global/regional positions, commercial
goals, and key stakeholders/partner lines.
- Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products.
- Develop and implement regulatory strategies to support/maintain
registrations. Maintain product licenses across all product platforms.
- Understand regulatory environment and communicate priorities to global/regional stakeholders
- Deliver project/product regulatory strategy, risk assessment, and PRS for assigned projects/products
- Develop and implement Regulatory Strategies for assigned
projects/products including assurance that project prioritization,
strategies, labeling, submissions, approvals, post-marketing lifecycle
management 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 Health Authorities (in
conjunction with PCOs) to facilitate the prompt review and approval of
applications, supplements/variations, and commitment closures.
Responsibilities
The major duties and responsibilities will include, but are not limited to:
- Contributing to Global/Regional regulatory strategies and
implementation plans (including core labels, risk registers) developed
for assigned projects/products. May also develop strategy and
implementation plans with appropriate level of supervision. Generally
assigned to projects of relatively small to moderate scope or
complexity.
- Ensuring regulatory contributions achieve clear-cut objectives
in the strategy, meet agreed standards, and minimize resource demands
while optimizing overall project delivery time and probability of
success and facilitating post-filing activities. Elevates issues where
appropriate.
- Partnering with project teams and other customer groups (e.g.,
Country Regulatory Managers, Brand Teams, PGS, etc.) to ensure required
regulatory contributions (line plans, IND, NDA, MAA, etc.) meet business
needs and are provided to the project teams, in accordance with agreed
time, cost and quality standards.
- Ensuring an aligned regulatory position is reached and
communicated for all key issues for assigned projects/products, and that
these regulatory positions supporting the business are championed and
communicated.
- Working closely with other Regulatory Strategists and CMC Team
within and across clusters/TAs and sites to ensure consistent and
appropriate processes, systems, working practices, shared learnings and
quality standards.
- Implementing systems, processes and procedures relating to
regulatory strategy productivity improvements, ensuring that these
facilitate the sharing of information across the relevant lines.
- Engaging in appropriate activities in order to influence the
regulatory environment through Health Authority contacts, Pfizer Country
Office partners and trade associations as appropriate.
- Ensuring business compliance and implementation of and adherence to regulatory standards.
- Developing and maintaining constructive working relationships with Health Authority contacts.
- Delivering the project/product regulatory goals and aligning the regulatory strategy with global/regional business needs.
- Ensuring regulatory plans are monitored, progress/variance is
communicated to Senior Management and any risks (from emerging technical
data, changing internal objectives or external threats) is mitigated
- Developing fit-for-purpose submission packages in collaboration with partner lines
-
Qualifications
- 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.
- Ability to partner successfully with Regulatory, Commercial, Safety, Medical and other partner lines to achieve objectives
- Experience in successfully communicating with major Health
Authority(ies), including participating in such interactions, is
preferred.
- Knowledge of assigned therapeutic areas/disease areas is preferred
- Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
- Ability to deliver in a highly matrixed organization.
- Strong written and verbal communication skills.
- Min 5 yrs of experience in managing global and/or regional
regulatory process and registration aspects of the drug development
process and post-marketing lifecycle management in the Pharmaceutical
Industry, preferably in Regulatory Affairs/Health Authority and/or
experience negotiating with Health Authorities and in representing
interests to internal and external stakeholders.
- Experience in managing regulatory issues and/or business processes is preferred
- Ability to deliver to time, cost, and quality standards
How to Apply
Interested and qualified candidate should:
Click here to apply
Note: When the page opens, enter the
Job Opening ID (1030874) in the Job ID Box, and click "Search"
Application Deadline 10th May, 2016.