Senior Manager, Global Regulatory Affairs Development - GI
Permanent (Full time)
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Manager, Global Regulatory Affairs Development - GI in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager working on the Global Regulatory Affairs Development - GI team, you will be empowered to lead the global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives, and a typical day will include:
- Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
- The Senior Manager role may include managing multiple projects or projects with greater complexity. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Provides strategic and tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- Responsible for developing solutions to identified risks and discussing with team and management.
- Accountable for all US FDA submissions and approvals for project(s) within scope; Serves as the primary FDA contact and can independently negotiate issues. The Senior Manager role may lead more complex submission types such as supplements or support GRLs for highly complex submissions.
- Contribute significantly to the preparation for Agency meetings; May lead FDA meeting with management oversight.
- Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
- Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
- Participate in departmental or cross-functional task-forces and initiatives.
- May participate on due diligence projects with oversight.
- Partner with functions responsible for ensuring market access and regional GRA leads to understand market access topics and strategize opportunities to strengthen product development plan(s) and build into global integrated regulatory strategy.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc Degree, preferred. BA accepted.
- 6+ years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 6+ years regulatory and/or related experience.
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
- Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
- Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Must work well with others and within global teams.
- Able to bring working teams together for common objectives.
- Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Manual dexterity required to operate office equipment (. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
Location and Salary Information:
- This job posting excludes CO applicants.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
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Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.