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Executive Director, Global Regulatory Sciences Cmc Advisory Office

Company

Pfizer

Address , New York, 10017, Ny
Employment type FULL_TIME
Salary $219,600 - $365,800 a year
Expires 2023-06-09
Posted at 1 year ago
Job Description
The GRS CMC Advisory Office Executive Director is recognized as an experienced and influential leader with global reach, relationships & responsibilities who leads & manages an advisory team within the GRS CMC organization.
  • Provides direct guidance & direction to project teams to mitigate regulatory risk & integrate CMC policy with product strategies driving learnings, consistency and regulatory excellence across the portfolio.
  • Partners with regional GRS colleagues to prioritize and influence CMC guidelines and regulations to ensure regulatory success of Pfizer’s development portfolio and compliance of on market products at the country level.
  • An outstanding regulatory leader & strategist routinely consulted internally, well connected externally and capable to lead interactions with regulatory agencies for shaping and development of regulatory policy initiatives
  • Partners effectively with other Pfizer colleagues to influence CMC policy and implementation externally, ensuring appropriate Pfizer representation on external trade association and scientific forums including PhRMA, BIO, ICH and others. Positive relationships and experience with key regulatory agencies globally.
JOB RESPONSIBILITIES
  • Ensuring appropriate Pfizer participation on key scientific councils and industry trade associations to influence strong scientific and regulatory decision making within Pfizer and externally with global regulators and other stakeholders.
  • Developing & advocating for policy positions related to CMC regulatory/quality issues in conjunction with GRS CMC leaders and PGS/ GRS Policy teams globally.
  • Cultivating & managing relationships with partner leaders in GRS CMC and with PGS, Med Sci, GRS & across Pfizer.
  • Ensuring all regulatory activities are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Advising teams to ensure globally robust regulatory strategies, leveraging both technical & regulatory knowledge and influence across Pfizer to ensure success and to mitigate risks.
  • Cultivating & maintaining a sustainable, cohesive, efficient, innovative & adaptive, integrated & aligned regulatory advisory office team predicated on well-grounded technical/scientific expertise, ensuring regulatory conformance & driving consistency globally.
  • Collaborating with regulatory regional teams to influence regional and country regulators and advance regulatory international harmonization prioritizing CMC topics critically important to Pfizer. Advise global, regional and local teams on global dossier approaches to speed development, registrations and approvals.
  • Communicate regularly with key stakeholders to ensure policy alignment. Contribute to GRS CMC LT operational initiatives & actions
QUALIFICATIONS / SKILLS
Education and Experience
  • Experience operating within GMP, GLP, or GCP related SOPs. Demonstrating global regulatory knowledge & experience, balanced judgment, crisp decision-making, exemplary collaboration & business acumen.
  • Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
  • Recognized as a technical subject-matter expert with extensive relevant regulatory experience & business knowledge. An outstanding regulatory leader & strategist routinely consulted internally, well connected externally and capable to lead interactions with regulatory agencies for shaping and development of regulatory policy initiatives.
  • One whom exercises independence in judgment and decision-making principles to influence regulatory & business strategy, guiding complex projects with broad impact and balancing risk with organizational flexibility & business needs
  • Advanced Scientific Degree (M.D., Ph.D., Pharm.D., M.Sc.) or equivalent experience in the biopharmaceutical industry.
  • Leads collaboration within & across divisions, working with other scientific & technical leaders, to establish aligned approaches to regulatory strategies and/or policies
  • Technical discipline with 20+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 10+ years pharmaceutical regulatory experience
  • Proven ability to work collaboratively within regulatory organization and across wider Pfizer including senior management and stakeholders. Established collaborative relationships within the Research, Development, PGS, and Commercial environments.
  • Proven track record of success in negotiating with global regulatory agencies and in representing interests to internal and external stakeholders.
  • Proven ability to function autonomously at a senior level in a highly matrixed organization.
Technical Skills Requirements
  • Exercising regulatory knowledge, experiential judgment and decision-making principles to influence regulatory & business strategy, guiding complex projects with broad impact to Pfizer and balancing risk with organizational flexibility & business needs.
  • Agile and entrepreneurial - Able to drive, anticipate, influence, and manage change, demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change to deliver maximum value for all stakeholders received
  • A recognized technical subject-matter expert with extensive relevant CMC regulatory experience & business knowledge.
  • Presentation and Analytical Skills - Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data to a variety of scientific and non-scientific audiences
  • Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines. Experience and credibility working with global regulators on pre and post market regulatory programs/issues.
  • High level of business acumen that includes development as well as commercial experience with a variety of therapeutic products.
  • Conflict Management - Able to act as mentor / coach to others to improve negotiation and conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and settle disputes equitably; provides direct and actionable feedback; prepared to take responsibility for a decision made and support this, even though it may be unpopular
  • An outstanding regulatory leader & strategist routinely consulted internally, well connected externally and capable to lead interactions with regulatory agencies for shaping and development of CMC regulatory policy initiatives.
  • Sufficient experience and knowledge to assess technical, scientific & regulatory merits of CMC strategies, commitments and data.
  • Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
  • Networking and Alliance Building - Achieves results through influence in a matrix organization and leverages contributions of colleagues with diverse expertise; builds strong alliances across internal/external stakeholder groups; proactively manages governance
  • Experience negotiating with regulatory authorities.
#LI-PFE
The annual base salary for this position ranges from $219,600.00 to $365,800.00. In addition, this position offers an annual bonus with a target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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