on of Regulatory Affair Management Requirments

8/8/2019 on of Regulatory Affair Management Requirments

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R&D Role Description

R&D Job Description

Position Title: Regulatory Affairs Manager

Zone / Line: WRS – Emerging MarketsLocation: Country (PCO) Based

Discipline / Job Family

Career Ladder (Level): Assoc. Dir. /

Director

Predicted Grade(s):

Position Purpose

The PCO based Regulatory Head will lead, mange and provide strategic direction and oversightto 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 basedteams (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 theRegulatory 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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• Develop strong partnerships with in-country (e.g. Country Managers, Medical,

Marketing, Supply Chain) and WRS-EM Therapeutic Area and Regional Teams tofacilitate 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 anddevelopment 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 environmentand 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 andcontract) 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 notessential.





• 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 leadershipexperience at senior management level is essential

• Demonstrable experience of effective delivery in a complex matrix environment.

Technical Competencies:

Competency Detail / Comments (specific skills, etc.)

Knowledge of the Regional and Globalregulatory environment and how this impacts

regulatory strategy and implementation.

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 withand influencing, opinion leaders, external

organizations and PCO’s facilitating approvalof submissions. Is driven to continuallyenhance regulatory expertise, both locally and

globally.

Knowledge of drug development practice,

rules, regulations and guidelines.

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.Strategic Thinker 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.

Communication skills Clearly conveys information and ideas through





a variety of media to individuals or groups in a

manner that engages the audience and helpsthem understand the message.

Negotiation skills Can negotiate skillfully in tough situations with

both internal and external groups. Can be directand forceful as well as diplomatic. Gains trust

quickly of other parties to the negotiations.

Has built a strong relationship with the localhealth 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 optionsand implement agreed upon solutions

Understands Business and Financial

Environment

Understands how role is impacted by and

contributes to external business environmentand financial drivers.

Understands Pharmaceutical Industry Understands and develops mitigation strategies

for issues and drivers impacting the

Pharmaceutical industry. Understands the needfor connectivity and active contribution to local

trade industry groups, being a recognized

regulatory professional partner, and thestrategic importance of this information to the

local business.

Behavioral (Core) Competencies:

Competency Detail / Comments (specific skills, etc.)

Understanding stakeholder needs Understanding internal and externalstakeholder needs to gain trust, settling

differences and winning concessions without

damaging relationships.

Network and alliance building/ peer

relationships

Uses an informal system of external and

internal contacts to facilitate and share ideas

and learning. Establishes and maintains a wide

range of relationships to support, guide andenable improved personal and organizational

performance. Can quickly find common groundand 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





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 andoutside the organization. Build constructive and

effective relationships, uses diplomacy and tactand 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 informalnetwork. 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 impactsto 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 workableregulatory strategies and issue mitigation.

Leadership and Management Understands difference between leadership andmanagement and can demonstrate ability to

adopt different styles contingent on businessneed.

Adaptability Able to build effective working relationships

and deliver results in wide range of environments and cultures.


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