R&D Role Description

R&D Job Description
Position Title:
Zone / Line:
Location:
Discipline / Job Family
Career Ladder (Level):
Regulatory Affairs Manager
WRS – Emerging Markets
Country (PCO) Based
Assoc. Dir. / Predicted Grade(s):
Director

Position Purpose

The PCO based Regulatory Head will lead, mange and provide strategic direction and oversight
to the
Country based regulatory teams to develop and execute regulatory strategies and plans for the
country and region, where applicable. The PCO based Regulatory Head would represent WRS-
EM on the Country Manager Leadership Team (CMLT) and local Country Medical Council (or
equivalent) to ensure collaborative connectivity with these key stakeholders (e.g. Commercial,
Medical, etc), and a more focused regulatory approach to supporting country business objectives.

Organizational Relationships:
• Direct Report to WRS-EM Regional RA Lead
• Dotted line reporting to the local Country Manager (Tier 1& 2 countries) and/or Country
Medical Director (Tier 3 countries)
• Member and strategic contributor to the Country Medical Council and other PCO based
teams (new product planning teams, etc.)
• Member and strategic contributor to the Regional RA Leadership Team (RALT Teams)

Resources Managed (budget and FTEs):

• Number of direct reports varies by country. Local RA staff lead and managed by the
Regulatory Head would consist of Senior RA Executives, RA Executives, RA Associates
and RA Administrators.
• Budget TBD – Responsible for local management of FTE/employment budget and travel
budget

Primary Duties:

• Lead and manage the local RA team in the development of regulatory strategies to
support the registration of clinical trial applications, new products, line extensions, major
variations and lifecycle management. Ensure that local RA teams provide strategic
regulatory input into WRS global regulatory strategies, thus providing optimal support
for meeting local business objectives.

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R&D Role Description

• Develop strong partnerships with in-country (e.g. Country Managers, Medical,

Marketing, Supply Chain) and WRS-EM Therapeutic Area and Regional Teams to
facilitate the development and implementation of registration strategies to expedite the
registration of new products, line extensions and life-cycle optimization.

• Provide strategic contribution to the country (PCO) leadership team – anticipate what
WRS-EM needs to contribute to achieve business objectives.

• Responsible for the development, leadership and performance management of the local
RA team to achieve company objectives. Develop and enhance the capabilities and
capacities of the RA teams through the identification and implementation of training and
development needs.

• Responsible for developing and enhancing relationships with key external agencies
(HA’s/BoH, RKOL’s, etc.). Manage the HA/BoH interface throughout the development
and lifecycle of a product.

• Active participation in local trade organization and effective communication to key

stakeholders of key issues that could impact regulatory strategies or the business.
Understand local regulations and developing trends in the local regulatory environment
and provide assessment of the impact to key stakeholders. Leverage regulatory
intelligence / landscape knowledge to support the development and implementation of
regulatory and business strategies.

• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations

by ensuring that corporate regulatory processes, SOP’s and systems (e.g. CMC change
control, product labelling, etc.) are in place, and that the local RA staff (permanent and
contract) are properly trained in these systems and procedures.

• Oversee and manage the completion of CTA (so will we be supporting CTA submissions
in future – EU moving to this are we?), NDA and Lifecycle (LC) submissions and
approvals as per established WRS-EM performance metrics.

Training & Education Preferred:

• Scientific Degree. A higher degree (MS or PhD) may be an advantage but is not
essential.

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R&D Role Description

• Appropriate Regulatory Experience – minimum 5 – 10 years experience

• Management Degree (Undergraduate or MBA) may be an advantage

Prior Experience Preferred

• Demonstrable experience across the Drug, Discovery, Development and
commercialization lifecycle, with proven examples of contribution.
• Proven ability to manage complex regulatory issues.
• Proven ability to consistently deliver to time, cost and quality standards.
• Regional regulatory experience including knowledge of CTA’s and NDA submission
processes and product life cycle management activities.
• General management experience and previous line management and leadership
experience at senior management level is essential
• Demonstrable experience of effective delivery in a complex matrix environment.

Technical Competencies:
Competency
Knowledge of the Regional and Global
regulatory environment and how this impacts
regulatory strategy and implementation.
Knowledge of drug development practice,
rules, regulations and guidelines.
Strategic Thinker
Communication skills
Detail / Comments (specific skills, etc.)
Understanding of regulatory agency
philosophies, culture, and developing trends in
the regulatory environment. Experience in
preparing and submitting CTA’s, NDA’s,
variations and LC submissions. Working with
and influencing, opinion leaders, external
organizations and PCO’s facilitating approval
of submissions. Is driven to continually
enhance regulatory expertise, both locally and
globally.
Familiarity with factors likely to influence the
regulatory environment, including new and
emerging guidelines relevant to Regional
regulatory strategies and implementation plans.
Maintains internal and external networks to
learn in advance about new regulatory trends or
changes impacting the Regulatory, Medical
and overall Business strategy.
Provides strategic contribution and anticipates
what RA needs to contribute to develop and
achieve business objectives. Effectively
explores alternative regulatory strategies and
positions to reach outcomes that gain the
support and acceptance of all parties.
Clearly conveys information and ideas through

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R&D Role Description

a variety of media to individuals or groups in a

manner that engages the audience and helps
them understand the message.
Negotiation skills Can negotiate skillfully in tough situations with
both internal and external groups. Can be direct
and forceful as well as diplomatic. Gains trust
quickly of other parties to the negotiations.
Has built a strong relationship with the local
health agency and other relevant stakeholders
(rKOL’s) and pro-actively manages issues with
the HA’s and other key external stakeholders.
Problem Solving Effectively identifies issues and challenges and
works with partner groups to identify options
and implement agreed upon solutions
Understands Business and Financial Understands how role is impacted by and
Environment contributes to external business environment
and financial drivers.
Understands Pharmaceutical Industry Understands and develops mitigation strategies
for issues and drivers impacting the
Pharmaceutical industry. Understands the need
for connectivity and active contribution to local
trade industry groups, being a recognized
regulatory professional partner, and the
strategic importance of this information to the
local business.

Behavioral (Core) Competencies:

Competency Detail / Comments (specific skills, etc.)
Understanding stakeholder needs Understanding internal and external
stakeholder needs to gain trust, settling
differences and winning concessions without
damaging relationships.
Network and alliance building/ peer Uses an informal system of external and
relationships internal contacts to facilitate and share ideas
and learning. Establishes and maintains a wide
range of relationships to support, guide and
enable improved personal and organizational
performance. Can quickly find common ground
and solve
problems for the good of all. Is seen as a team
player and is cooperative.
Influencing Uses a range of communication styles and
choosing appropriate strategies to deliver goals

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against a backdrop of diverse agendas,

priorities and cultures.
Team working Comfortable acting in a wide range of team
roles in the wider project interest.
Interpersonal acumen Relates well to all levels of people inside and
outside the organization. Build constructive and
effective relationships, uses diplomacy and tact
and can diffuse high-tension situations
comfortably.
Organizational agility Knowledgeable about how an organization
operates and knows how to get things done
both through formal channels and the informal
network. Understands the origin and reasoning
behind key policies, practices and procedures.
Perspective Looks toward the broadest possible view of
issues/challenges and is able to project impacts
to the future.
Strong quality and compliance orientation Has an understanding of regulatory compliance
issues and the potential impact of compliance
related issues on meeting business objectives.
Analytical Thinking Can analyze large quantities of complex
scientific data and synthesize this with external
regulatory environmental trends into workable
regulatory strategies and issue mitigation.
Leadership and Management Understands difference between leadership and
management and can demonstrate ability to
adopt different styles contingent on business
need.
Adaptability Able to build effective working relationships
and deliver results in wide range of
environments and cultures.

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