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Senior Regulatory Affairs Associate


Hanoi, Hà Nội
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Job Details

**Position Purpose**

+ To assist Head of Regulatory Affairs Head to provide leadership and strategic direction of specific in-country PEH BU portfolio

+ To interface with other function leads (e.g. GCMC, GLS, SOS, PGS, Commercial, Medical) to ensure collaborative connectivity with these key stakeholders, and a more focused regional RA approach to supporting country and regional business objectives and ensure product access (PNS).

+ Delivery of innovative pharmaceutical products with competitive labelling to the region in timely manner.

+ Be a recognised partner for internal in-country stakeholders (GCMC, SOS, GLS, PGS, Medical, Commercial etc.)

+ Establish, and maintain, strong relationship with the regulatory authorities.

+ Environment shaping and advocacy activities within country/region

**Primary Responsibilities**

**Regulatory Support**

+ Manage the development of regulatory strategies to support the registration of clinical products, line extensions trial applications, new, major variations & lifecycle management.

+ 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 RA staff (permanent and contract) are properly trained in these systems and procedures.

+ Oversee & manage the completion of CTA, NDA & Lifecycle (LC) submissions & approvals as per established PEH GRA performance metrics & Alliance Partner model.

+ Responsible for ensuring that all regulatory activities (new product submissions, clinical trial applications, existing licenses, etc.) are compliant with local regulations, requirements and practices.

+ Provide input to the relevant stakeholders for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) & alignment is achieved between regulatory activities and relevant country business/commercial plans.

+ Provide consultative and intelligence support to internal stakeholders. Advise where necessary, on the development of responses to regulatory queries, including coordination on the receipt, distribution and response to regulatory queries on assigned projects, consistent with departmental procedures.

+ Responsible for the development, leadership and performance management of the direct reports (where applicable) to achieve company objectives. Develop and enhance the capabilities and capacities of the direct reports (where applicable) through the identification and implementation of training and development needs.

+ Develop strong partnerships with in-country & regional teams (e.g. Country Managers, Medical, Marketing, Supply Chain) to facilitate the development &implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.

+ Provide strategic contribution to the PEH GRA leadership

+ Contribute to change management and continuous improvement projects (Regulatory Operational Excellence).

+ Responsible for developing and supporting relationships with key external agencies. Support the Health Authority interface throughout the development and lifecycle of a product. Support long-term and positive relationship characterized by integrity, quality, compliance and leadership. Facilitate meetings and participate in negotiations with regulatory authority as necessary.

+ Active participation in regional trade organization and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand regional 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.


+ Ensure effective communication and collaboration with stakeholders and other function leads (e.g. GCMC, RegOps, PGS, Commercial, Medical etc.)

+ Interact and participate in negotiation discussions on regulatory matters concerning Pfizer's portfolio/interest and also involve in relationship building with Regulatory Authorities and Industry Associations, as appropriate.

+ Monitor, analyse, interpret and inform Head of Regulatory Affairs (PEH GRA) regarding regulatory trends and events including matters such as regulatory guidelines, regulatory environment/climate issues, regulation and external meetings concerning regulatory matters.

+ Support Head of Regulatory Affairs (PEH GRA) to anticipate changes in country registration policies and guidelines and keeps relevant Pfizer groups informed of changes in the regulatory environment.

+ Keep abreast of the external regulatory environment, including competitor intelligence, local product and international regulatory and commercial strategies.

+ Monitor and consult Head of Regulatory Affairs (PEH GRA) for dissemination of information on changes to regulations affecting registration, manufacture, distribution and sale of Pfizer products.

**Environment shaping**

+ Monitors, analyzes, interprets and informs Head of Regulatory Affairs (GRA PEH) regarding regulatory trends and events including changes in matters such as regulatory guidelines, regulatory environment/climate issues, regulations, competitor intelligence and external meetings concerning regulatory matters.

+ Support Head of Regulatory Affairs (PEH GRA) to anticipate changes in country registration policies and guidelines and keeps relevant Pfizer groups informed of changes in the regulatory environment.


+ Support the overall strategic direction, staffing, budget input for the Head of Regulatory Affairs (PEH GRA) and training of the Regulatory Affairs Group, in accordance with the Pfizer SOPs and Core Values.

+ Participate in the relevant Regulatory Affairs meetings and support Head of Regulatory Affairs (PEH GRA) in encouraging interdepartmental communication.

+ Develop systems and process improvements to continuously improve support for Pfizer in the market place.

+ Participate in and promote team building and provide a stimulating environment which encourages team and individual growth.

+ Effectively plan and monitor self-performance to meet set objectives.

+ Own self-development, performance management and career planning.

**Inventory Support**

+ Support Head of Regulatory Affairs (PEH GRA) in coordinating with PGS (and other relevant stakeholders), to ensure stock availability to local market, while strategically planning the timing to ensure stocks availability for new product launches.

**Marketing Support**

+ Support the development/review of promotional materials that are in keeping with Pfizer's standards by providing latest labelling information and strategizing product labelling to Pfizer's benefit.

+ Provide regulatory input to Head of Regulatory Affairs (PEH GRA) to support marketing plans, product launches and other cross-functional activities

**Regulatory Compliance**

+ Be accountable for regulatory compliance (of records and systems) within the area of responsibilities.

+ Complete relevant training activities and comply with relevant standards in the local office to ensure compliance to local, international regulations and Pfizer SOPs.

+ Support Head of Regulatory Affairs Head (PEH GRA) to ensure registered products are maintained in full compliance with all relevant legislation and SOP procedures.

+ Coordinate with Head of Regulatory Affairs Head (PEH GRA) on product recall activities with sales, marketing, logistic and distributor which may be required by manufacturer or Regulatory Authority.

**Project Management:**

+ Oversee and/or facilitate strategic process improvements initiatives.

+ Ensure product strategies, submission and approval time lines.

**Technical Skill Requirements**


**Detail / Comments (specific skills, etc.)**

Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation.

Understanding of regulatory agency philosophies and guidelines. Experience preparing and submitting CTA's, NDA's, variations and renewals. Working with and influencing, opinion leaders, external organizations and PCO's facilitating approval of submissions.

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.

Understands Business and Financial Environment

Understands how role is impacted by and contributes to external business environment and financial drivers

Understands Pharmaceutical Industry

Understands and develops mitigation strategies for issues and drivers impacting the Pharmaceutical industry

**Behavioral Competencies:**


**Detail / Comments (specific skills, etc.)**

Understanding stakeholder needs

Understanding internal and external stakeholder needs to gain trust, settling differences and wining concessions without damaging relationships

Network and alliance building/ peer relationships

Uses an informal system of 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


Uses a range of communication styles and choosing appropriate strategies to deliver goals against a backdrop of diverse agendas, priorities and cultures

Communication skills

Communicates effectively using a variety of mediums appropriate to the setting

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 key external and internal stakeholders.

Problem Solving

Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed solutions

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


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


Able to build effective working relationships and deliver results in wide range of environments and cultures

**Qualifications (i.e., preferred education, experience, attributes)**

+ Scientific degree (preferably a pharmacist).

+ If pharmacist, may be required to be a registered pharmacist with the local Pharmacy Board and hold Pharmacist Poison A License, upon agreement

+ Appropriate Regulatory Affairs experience - minimum 3-5 years is preferred.

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

+ Fluent in English - written and spoken communication skills

+ Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.

+ Proven ability to manage 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 maybe an added advantage.

+ Demonstrable experience of effective delivery in a complex matrix environment

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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