Job at Pfizer for a Senior Manager, Regulatory Strategist
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: Senior Manager, Regulatory Strategist
Job ID: 1030873
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 independence and
supervision. 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,
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.
- 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
Responsibilities
The major duties and responsibilities will include, but are not limited to:
- Developing or contributing to Global/Regional regulatory
strategies and implementation plans (including core labels, risk
registers) developed for assigned projects/products, with an
appropriate level of independence and supervision. Generally assigned
to projects of relatively moderate to significant scope or complexity.
- 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.
- Ensuring regulatory contributions achieve objectives of various
complexity 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.
- 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.
- 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.
- Min 7-8 yrs of proven 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 managing multiple products simultaneously and different
stages of the product lifecycle is highly desirable.
- Proven 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 leading and 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.
- Proven ability to deliver in a highly matrixed organization.
- Strong written and verbal communication skills
- Ability to work well with appropriate level of independence and a moderate level of supervision.
- Relevant Global and/or Regional regulatory experience
- Experience in managing regulatory issues and/or business processes
- Proven 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 (1030873) in the Job ID Box, and click "Search"
Application Deadline 10th May, 2016.