Job Title

Associate Director of Regulatory Affairs ? Established Products

Job Description

Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description
Associate Director is responsible for the development of global CMC regulatory strategies, completion of regulatory submissions and regulatory compliance for a portfolio of development programs and commercial products supporting the Global Established Pharma Business Unit.

Generates the CMC regulatory strategy assessing the risks, coordinates and completes the preparation of CMC regulatory documentation.

Acts as the Global CMC representative or supports to the Global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.

Accountable for assigned CMC portfolio, managing daily delivery of regulatory and strategic activities, including clinical trials, Life Cycle Teams and compliance of commercial products.

Depending on experience, may operate independently to resolve complex regulatory issues and manage regulatory risks and ambiguous situations. Examines opportunities for regulatory innovation and promote the use of novel approaches within project team to resolve issues and problems.

Creates and contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the Pfizer pharmatherapeutic portfolio at large.

Responsibilities
Serves as a GCMC strategist for projects within product portfolios, providing regulatory assessments and developing regulatory strategies.

Acts as the Global CMC representative, or contributes support to the Global CMC representative, within cross-functional project teams. Accountable for assigned projects and activities, independently completing work within assigned work group/project teams for multiple projects.

Interprets CMC regulatory requirements, develop strategies (including novel approaches), assess risks and develops contingencies. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.

Responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.

Ability to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the Pfizer pharmatherapeutic portfolio. Manages the resolution of regulatory CMC/information management issues with project/program stakeholders.

Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives.

Qualifications
Education and Experience:
BS/MS/PhD in a scientific/engineering/pharmaceutical development sciences degree. Must have a minimum of 15 years relevant pharmaceutical development and/or manufacturing experience with a clear understanding of drug development/commercial manufacturing of pharmaceutical products. Must have a minimum of 5 years in-depth drug substance or drug product manufacturing and/or development experience across multiple dosage forms.

An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain. Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio.

Technical Skills Requirements:
Technical and scientific understanding of pharmaceutical drug development and manufacturing with technical writing skills. May serve as Subject Matter Expert in specific relevant disciplines or recognized as a regulatory CMC resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains.

Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum via web interface). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.

Physical Position Requirements:
General office based activities, requiring the operation of telephone and computer systems. Occasional business travel.

Equal Employment Opportunity
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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Desired Skills and Expertise

Bachelor's Degree

Industry

Pharmaceutical

Experience

5+ years

Job Type

Full Time

Salary / package

Not Specified