Regulatory Affairs Manager CONTRACTOR 1 YEAR

at  Pfizer

Job Summary:
The Regulatory Affairs Manager will lead, manage, and provide strategic direction and oversight to the Head of regulatory affairs and above regulatory teams to develop and execute regulatory strategies and plans for the country.

Job responsibilities:

• Manage the assigned portfolio in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management. Provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives under Country Regulatory Head lead.
• Develop strong partnerships with in-country (e.g. BU leads, Market Access, Marketing, Supply Chain) and with above country (e.g. Country Strategists, GCMC Hub, Submission and labeling/artwork Hubs, 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.
• Responsible for their own personal development, leadership and performance to achieve company objectives and agree training and development needs with Country Regulatory Heads to develop and enhance individual capabilities and capacities.
• Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, Regulatory KOL’s, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product.
• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems are followed ensuring training in P2L are completed 100% (systems and procedures).
• Maintain compliance at 100% in all regulatory systems.Where needed, oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established EM performance metrics.

Attributes:

• Understanding stakeholder needs

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

• Knowledge of the Regional and Global regulatory 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 with and influencing, opinion leaders, external organizations and CRL’s facilitating approval of submissions. Is driven to continually enhance 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 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 (regulatory KOL’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.

• Detailed Orientated

Can be thorough and complete with high quality.

• Project Management

  Can manage complex and multiple projects.

Experience:

• minimum of 3-5 years’ experience in regulatory affairs preferably in human medicine.
• Demonstrable experience across the Drug, Discovery, Development, and commercialization lifecycle, with proven examples of contribution.

Regulatory competencies:
Behaviors & Soft Skills
Models high levels of engagement and fosters similar behaviours in others. Demonstrates a high level of integrity in decision making on regulatory issues in line with company values. Develops and maintains effective relationshipsboth internally & externally. Culturally sensitive. Openly shares information cross-functionally. Successfully negotiates with others to resolve technical and regulatory solutions.
Leadership
Independently leads cross functional teams for products/projects assigned, with moderate oversight from manager on complex issues. Effectively manages regulatory activities for defined function or market and drives issues to resolution in a timely manner. Aware of broader business impact of regulatory strategies and timelines. Escalates issues with significant business impact where necessary.
Innovation and Problem Solving
Identifies improvements to standard practices. Proposes changes to agreed strategies in line with revised guidelines or business priorities.
Impact of Decisions
Decisions impact work of multiple work teams or departments and it’s customers. Decisions have short-term effect on program/project delivery.
Direction Received
Works independently. Receives instruction primarily on unusual or complex issues.
Communication
Effectively communicates regulatory position to teams and management in order to achieve consensus.
Technical Expertise
Sound understanding of regulatory processes and requirements for defined market(s) and able to translate into product strategies. Develops innovative regulatory strategies for moderately complex regulatory projects/issues and makes recommendations to project teams and senior management. Participates in regulatory meetings.
Pfizer Gulf is an equal-opportunity employer, and we are proud of our commitment to creating a diverse and inclusive candidate pool to support and empower our workforce.
We strive to ensure that our people are heard, seen and cared for by creating an environment that fosters inclusion and inspires colleagues to speak up to promote an engaging and inclusive culture where they can thrive.
Our diverse workforce represents the patients we serve and the communities in which we operate.
We look forward to reviewing your application and thank you for your interest.
Regulatory Affairs

• Manage the assigned portfolio in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management. Provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives under Country Regulatory Head lead.
• Develop strong partnerships with in-country (e.g. BU leads, Market Access, Marketing, Supply Chain) and with above country (e.g. Country Strategists, GCMC Hub, Submission and labeling/artwork Hubs, 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.
• Responsible for their own personal development, leadership and performance to achieve company objectives and agree training and development needs with Country Regulatory Heads to develop and enhance individual capabilities and capacities.
• Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, Regulatory KOL’s, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product.
• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems are followed ensuring training in P2L are completed 100% (systems and procedures).
• Maintain compliance at 100% in all regulatory systems.Where needed, oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established EM performance metrics