Regulatory Strategy Manager
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Job Location:
Boston, NH - USA
Monthly Salary:
$ 124000 - 186000
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description
General Summary:
The Regulatory Strategy Manager will be responsible for regulatory support for development programs or marketed products. The Regulatory Strategy Manager will contribute to the development of US regional or global regulatory strategies for development and commercialization of program(s) within the portfolio. This role requires a good understanding of regulatory affairs frameworks the drug development process and related concepts.
Key Duties and Responsibilities:
- Contributes to the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team
- Develops proficiency in regional and global regulatory skills
- Supports global regulatory strategy under guidance of the Global Regulatory Lead
- Responsible for regulatory communications with local health authority; under supervision may lead regulatory interactions with the health authority
- Identifies regulatory requirements for development and approval pathways for assigned region
- Under supervision manages the process for preparation submission and approval of regulatory applications within assigned region
- Provides technical regulatory input for key product development or registration documents
- Works to ensure compliance of regulatory submissions with current regulations and guidance
- Reviews regulatory intelligence and guidance information to continuously support regulatory strategy in assigned region
Knowledge and Skills:
- Good knowledge of regional regulatory affairs frameworks
- Understanding of requirements and processes to maintain a product on the market; reporting and surveillance
- Understanding of drug development and related concepts such as clinical trial design statistics and clinical pharmacology
- Ability to assess and understand complex scientific information regulatory precedent competitive intelligence and regulatory guidelines
- Strong problem-solving skills
- Strong written and verbal communication skills to exchange complex information with others in complex situations
- Ability to work effectively within a team environment
- Ability to plan prioritize and contribute to work and projects in a systematic and efficient manner
Education and Experience:
- Bachelors degree in Biology Chemistry or other related discipline
- Typically requires 4 years of relevant pharmaceutical or biotech industry experience or the equivalent combination of education and experience
Pay Range:
$124000 - $186000Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:
In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at
Required Experience:
Manager
Key Skills
- Marketing
- Data Visualization
- Tableau
- Customer Segmentation
- Microsoft Powerpoint
- Investment Banking
- Strategic Planning
- Financial Modeling
- Customer relationship management
- Management Consulting
- Google Suite
- Analytics
About Company
Vertex Pharmaceuticals invests in scientific innovation to create transformative medicines for people with serious diseases.
