Project Manager

4 weeks ago


Boston, United States Artint Knowledge Tech Full time

Role: Project Manager

Location: Seaport HQ, Boston, MA

Must have Pharmaceutical background

Min 10+ Years profile

You will be responsible for:

- Developing and directing innovative and effective regulatory strategies in support of

specific projects, and across projects in the Alexion portfolio.
- Serving as global or US Strategy lead on assigned programs. Acting as submission

sub-team lead for US submissions and is core member of Regulatory Subteam (RST)

for assigned programs.
- Providing advice on regulatory issues for both marketed and pipeline products; actively

collaborates with management, Global Regulatory Lead and cross functional colleagues

within Alexion (i.e., commercial, research, clinical development, medical affairs,

business development, legal, manufacturing, quality, portfolio management, financial,

human resources, etc.).
- Accountable for preparation and execution of regional aspects of the regulatory global

strategy. Can include setting direction for junior staff to execute regional regulatory tasks

according to strategy.
- Representing Alexion as point contact FDA and leading Alexion delegation for

regulatory authority meetings.
- Leading US submissions to regulatory authorities in support of proposed and ongoing

development programs, e.g., new clinical trial protocols, new marketing authorisation
- Monitoring the development of new regulatory requirements or guidance documents

and advising product teams of the impact on the business or development programs.

Providing support to regulatory affairs reviewers for due diligence initiatives, including

opportunity and risk assessment.
- Ensuring exemplary behavior, ethics and transparency within the company and with

regulatory agencies.

You will need to have:

- Strong knowledge of US drug development and regulatory policy; excellent scientific

and business judgment.
- Experience providing US strategic regulatory advice for the global development of

products through all stages of development including pre-approval and marketed

compounds.
- Experience with leading major submissions and FDA meetings
- Ability to manage complex issues and coordinate multiple projects simultaneously
- Ability to build intra-team relationships and collaborate in a global team environment at

all levels of the organization.
- Strong interpersonal, and written/verbal communication skills.
- Proven track record practicing sound judgment as it relates to risk assessment
- Highly conversant and knowledgeable of new and emerging regulations and

guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to

seek and how to interpret regulatory information.
- Bachelor’s Degree in a related discipline

**Job Types**: Full-time, Contract

Pay: Up to $70.00 per hour

Schedule:

- 8 hour shift

Ability to Relocate:

- Boston, MA 02118: Relocate before starting work (required)

Work Location: Hybrid remote in Boston, MA 02118



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