Regulatory Affairs Senior Manager CMC

2 days left

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Posted
Jun 06, 2021
Closes
Jun 14, 2021
Ref
549743
Jobseeker Type
Professional
Organization Type
Corporate
Hours
Full Time
Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will help Pfizer develop and implement chemistry, manufacturing and control (CMC) regulatory strategies for small and large molecule pharmaceuticals and devices to meet global regulatory requirements throughout the life cycle. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the company on communications and in meetings with health authorities, assessing impact of new regulations, manages regulatory documents, etc. You will also be in a position to negotiate with regulatory authority personnel to expedite approval of pending registrations and respond to queries.

As a Senior Manager, your advanced knowledge of the principles and concepts in the area of regulatory affairs and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements.

It is your leadership skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Develop ideas and lead/co-lead complex projects across division, and develop and manage plans to achieve objectives.
  • Ensure regulatory conformance & consistency globally in compliance with external regulatory requirements and internal quality procedures.
  • Investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
  • Develop effective relationships with local & global internal partners, i.e., Research and Development, Pfizer Global Supply Worldwide Strategy and Regulatory Business Units, etc.
  • Serve as a CMC strategist and project leader for projects within the global Pfizer Biopharmaceuticals Group Hospital Category Anti-Infectives portfolio, providing regulatory assessments and developing regulatory strategies independently or with minimal supervision.
  • Lead the preparation of CMC information for submission to regulatory agencies, generate CMC strategies, assesses risks and develops contingency plans, including major, complex applications.
  • Execute training related activities {e.g. compliance-related, HR policies) and individual development plans, participate in cross-disciplinary forums & learning opportunities.
  • Demonstrate and model adherence to all Pfizer behaviors & values, embrace and comply with Global Chemistry Manufacturing and Controls Principles of Integrity.
  • Serve as a technical and scientific resource within own work group and provide guidance for completion of difficult and complex projects.


Qualifications

Must-Have

  • BS Scientific/engineering/pharmaceutical development sciences degree, plus 9+yrs experience; Master's (MA/MBA/MS) plus 7+years experience.
  • Experience in CMC supporting clinical, initial registration, and post approval programs with diverse dosage forms, particularly sterile products, is desirable.
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop, and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  • A demonstrated regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain.
  • Must have a minimum of 15 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience.
  • Must have a minimum of 3 years drug substance or drug product development or manufacturing technical support experience.
  • Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio.
  • Candidate is required to have a sound understanding and advanced functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with a clear understanding of drug development/commercial manufacturing of biologics pharmaceutical products, including technical and scientific understanding of pharmaceutical drug development with technical writing skills.
  • Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum).
  • 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.
  • The candidate is required to have a clear track record of effective teamwork, collaboration, communication, and demonstrated leadership ability in a cross-functional matrix team environment.
  • Product management along with planning/organizing by prioritizing and planning work activities and change agility are also essential attributes.


Nice-to-Have

  • Master's/PhD degree
  • Relevant pharmaceutical experience
  • Experience managing projects
  • Experience with diverse dosage forms, particularly sterile products


Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS
  • Normal office based and needs to be able to travel on public transport, including international.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Travel to external (trade association or agency) or internal meetings as required.


Other Job Details:

  • Last Date to Apply for Job: 06/04/2021
  • Additional Location Information: United Kingdom - Sandwich; United States - Michigan - Kalamazoo; United States - New Jersey - Peapack; United States - Connecticut - Groton; Ireland - Kildare - Newbridge;United States - Massachusetts - Andover;
  • No Relocation Package offered
  • Eligible for Employee Referral Bonus


#LI-PFE

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EEO & Employment Eligibility

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.

Regulatory Affairs