1+ months

Regulatory Strategist EU ROW (Biosimilars)

Pfizer
Cambridge, MA 02139
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**ROLE SUMMARY**



+ Provide support for the EU and Global Biosimilar regulatory strategy contribution that aligns with regional and global business needs.

+ Lead and manage Biosimilar regulatory strategy aspects of projects/products across the lifecycle, including the preparation and submission of correspondence and applications to regulatory agencies.

+ Act as direct liaison with regulatory authorities / Pfizer country offices to facilitate the prompt review and approval of applications.

+ Supporting early and late clinical development activities by providing regulatory advice.

+ As appropriate develop and implement regulatory strategies to support initial registrations

+ Maintains product licenses across all product platforms.

+ Understand regional regulatory environment and communicates priorities to global stakeholders.

+ Support delivery of project regional strategy.

+ Participate on Regulatory Team and contribute aligned (i.e. with other regional stakeholders) regional strategy for assigned project / products.

+ Provide support for the EU and Global Biosimilar regulatory strategy contribution that aligns with regional and global business needs. As appropriate accountable for regional regulatory agency interactions.

+ Lead and manage Biosimilar regulatory strategy aspects of projects/products across the lifecycle, including the preparation and submission of correspondence and applications to regulatory agencies.

+ Act as direct liaison with regulatory authorities / Pfizer country offices to facilitate the prompt review and approval of applications.

+ Supporting early and late clinical development activities by providing regulatory advice.

+ As appropriate develop and implement regulatory strategies to support initial registrations

+ Maintains product licenses across all product platforms.

+ Understand regional regulatory environment and communicates priorities to global stakeholders.

+ Support delivery of project regional strategy.

+ Participate on Regulatory Team and contribute aligned (i.e. with other regional stakeholders) regional strategy for assigned project / products.

+ As appropriate accountable for regional regulatory agency interactions.



**ROLE RESPONSIBILITIES**

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



+ Leading contribution to Regional and Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.

+ Ensures regulatory contributions achieve the objectives of the strategy, achieve agreed standards, minimize resource demands whilst maximizing overall project delivery time and probability of success and facilitating post filing activities.

+ Extensive experience in leading and directing contributions and communication of complex Regulatory Strategies both at the team level and to management/ governance.

+ Leads and partners with project teams and other customer groups (e.g. Country Regulatory Managers and Commercial Teams) to ensure required regulatory contributions (CTA/IND, MAA/NDA/BLA, supplements/variations, license renewals etc) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.

+ Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated

+ Partners with Regional, Medical, Regulatory and Commercial colleagues including, Country Regulatory Managers.

+ Ensures an aligned regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the business are championed and communicated.

+ Works closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.

+ Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines

+ Ensures business compliance and implementation of and adherence to Regulatory standards.

+ Develops and maintains constructive working relationship with Health Authority contacts as appropriate, as well as relevant experts and key opinion leaders.

+ Ensures alignment with Global Regulatory Lead and GRPL



**BASIC QUALIFICATIONS**

"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."



+ Bachelor's degree or equivalent/graduate degree in a Scientific field.

+ 9-13 years of experience in EU and/or Global regulatory affairs, preferably in human medicines.

+ Proven ability to manage complex regulatory issues.

+ Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.

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

+ Demonstrable experience of effective delivery in a complex matrix environment.

+ Strong strategic thinking, project management, team working, problem solving, communication and interpersonal skills.

+ Knowledge of national/regional and global regulatory legislation and guidelines.

+ Understanding of business and financial environment, drug development process and the pharmaceutical industry.

+ Knowledge and understanding of quality systems, processes, audit and inspections.

+ Ability to influence at all levels in the organization and build networks internal and externally.



**PREFERRED QUALIFICATIONS**



+ A higher degree (MSc, MBA or PhD) may be an advantage but is not essential.

+ Oncology, biosimilars development experience an advantage.



**Other Job Details:**



+ Eligible for Employee Referral Bonus: Yes



**\#LI-PFE**



**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
Posted: 2020-02-25 Expires: 2020-04-27

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Regulatory Strategist EU ROW (Biosimilars)

Pfizer
Cambridge, MA 02139

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