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Sr Director / Team Leader, Essential Health, Regulatory CMC


Peapack, NJ
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Job Details

Job Title Sr Director / Team Leader, Essential Health, Regulatory CMC

JobID 1616763

Location: Peapack, NJ

Description Role Summary

+ Be a lead regulatory representative for the global Chemistry, Manufacturing, & Controls (CMC) Area within the PEH GRA Brands team.

+ Oversee the designated CMC area at the strategic and technical level.

+ Be accountable for the CMC Regulatory Strategies working across the therapeutic area teams, ensuring aligned regulatory positions in place and agreed that take account of regional needs.

+ Provide strategic guidance to projects and products through CMC team leads and/or CMC strategists and reporting to him/her.

+ Model strong leadership and project management techniques to provide leadership to the PEH GRA Brands teams, committees or work units to develop objectives, strategy, and tactical plans for the portfolio, assuring a global focus of goals, strategies and plans.

+ Responsible for supporting the development of collaborative working relationships with the regulatory authorities and influencing emerging regulations/policies in general and particularly in the CMC area.

+ Supervise CMC team leads and/or CMC strategists. Responsible for staff and talent development, career development and planning and performance management.

+ Directly accountable for ensuring CMC regulatory deliverables (strategies, labeling, submissions, approvals, post-marketing lifecycle management activities, etc.) are in place and delivered in accordance with time, cost and quality expectations for all projects in portfolio.

+ As a member of the PEH GRA Brands CMC leadership team, contribute to overall management, alignment and process improvement and drive the appropriate culture and behaviors through the organization.

+ Champion flexible approaches to ensure efficient and effective resource utilization.

+ Ensure learnings are embedded in the organization.

The major duties and responsibilities will include, but are not limited to:

+ Provide CMC regulatory expertise and leadership across her/his portfolio as a senior global CMC regulatory representative within the PEH GRA Brands team, responsible for regulatory decisions at the strategic and technical level.

+ Responsible for developing and maintaining in-depth CMC regulatory knowledge of the portfolio including current and emerging guidelines and regulations (Quality and CMC), relevant regulatory approaches and actions, and ensuring that knowledge is shared across team(s) to enable efficient and effective achievement of project and portfolio goals.

+ Responsible for ensuring global CMC regulatory strategies for all projects and products are developed and implemented (including risk registers, change management plans, etc.)

+ Ensure all CMC regulatory contributions (strategies, labeling, submissions, approvals, post-marketing lifecycle management activities, etc.) achieve the objectives agreed with the BU, PGS, stakeholders, and partner lines in accordance with time, cost, and quality expectations

+ Ensure global CMC regulatory plans are monitored and progress/variance communicated to leadership and appropriate stakeholders, and any risks from emerging technical data, changing internal objectives or external threats are appropriately mitigated

+ Ensure an aligned global CMC regulatory position is reached and communicated for all key issues and that CMC regulatory positions supporting the global and regional business(es) are appropriately championed and communicated.

+ Develop strong and positive working relationships with Manufacturing and collaborate on the development and execution of CMC strategies.

+ Develop strong and positive working relationships with regulators, professional bodies, external experts and opinion leaders.

+ Develop novel concepts and approaches to advance and/or challenge existing CMC regulatory paradigms.

+ Work closely with regulatory colleagues across sites, countries and TAs to ensure consistent approaches to Health Authorities.

+ Engage in appropriate activities to influence the CMC regulatory environment.

+ Contributes to CMC resource forecasting for the projects/products within assigned portfolio(s) and works in collaboration and cooperation with other members of the Brands CMC LT to ensure that adequate resources are assigned to projects within the PEH GRA Brands CMC portfolio

+ Mentor, develop and coach CMC team leads and CMC strategists for projects within the relevant portfolio(s) including all aspects of the performance management process as appropriate.

+ Provide guidance to all CMC regulatory professionals with the area of responsibility to prepare for health authority interactions and external and internal project/product presentations.

+ Work with other regulatory staff to ensure application of consistent processes and policies across PEH GRA. Directly responsible for ensuring implementation of these processes and policies.

+ Support the PEH GRA Brands CMC leadership team and drive the required culture and behaviors through the organization.

+ Champion flexible approaches to ensure efficient and effective resource utilization.

+ Ensure team maintains compliance in accordance with all appropriate standards.


+ B.S. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.

+ Must have a minimum of 10 years relevant pharmaceutical development and/or manufacturing experience with a minimum of 5 years of drug substance or drug product development or technical support experience. Experience with diverse dosage forms including sterile injectables and combination products is desirable.

+ Proven experience in managing global and/or regional CMC regulatory process and registration aspects of the drug development process and post-marketing lifecycle management in the Pharmaceutical Industry, preferably in Regulatory Affairs/Health Authority and/or a proven track record of success in negotiating with Health Authorities and in representing interests to internal and external stakeholders. Experience managing multiple products simultaneously within or across therapeutic areas and different stages of the product lifecycle is highly desirable.

+ Proven ability to manage complex CMC regulatory issues and business processes.

+ Proven ability to manage a team of CMC regulatory professionals, remote management experience desired.

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

+ Proven ability to partner successfully with Regulatory, Manufacturing, Commercial, Safety, Medical and other partner lines to achieve objectives.

+ Experience in successfully communicating with major regulatory agency(ies) on CMC issues, including leading and participating in such interactions, is preferred.

+ In depth and relevant Global CMC regulatory experience (more than one region).

+ Demonstrated strategic thinking and ability to integrate strategies into actionable plans.

+ Proven ability to function autonomously at a senior level in a highly matrixed organization.

Physical Position Requirements:

+ Some international travel required.

**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.

**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.

Additional Posting Details:

+ Pfizer Grade 19

+ Eligible for Employee Referral Bonus

+ Last day to apply: October 30, 2017

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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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