Massachusetts Veterans Jobs

associate director us regulatory, biosimilars.

• cambridge , massachusetts (remote)

• posted july 11, 2024

job details

summary

• $150 - $165.37 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference48454

job details

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!

location: Telecommute

job type: Contract

salary: $150.00 - 165.37 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

The US Regulatory Associate Director will be responsible for developing and delivering innovative regulatory strategies for Biosimilar product development, approval, and LCM activities for assigned assets in the US, in alignment with the global business strategy. Responsible for contributing to the Global Regulatory Plan and strategy for the US territory and accounting for the requirements of the FDA and other regulatory bodies. Responsible for leading the regulatory activities for the development, registration, and Life-Cycle Management of Biosimilar asset(s) in the US, across multiple indications and/or development stages and for ensuring compliance. Represent the company with domestic regulatory authorities, contractors, and corporate partners. Management of outsourcing and vendor management for in-country RA execution where needed. Lead and oversee Biosimilar regulatory policy, coordinating and providing input from BBU in partnership with internal policy teams. Co-ordination and oversight of Biosimilar regulatory Ad/Prom activities in close partnership with internal Ad/Prom teams. Working across various project teams, workstreams, functions, partners, and committees. Steering and supporting regulatory team members and/or direct reports (as applicable)

• Responsible for directing US regulatory strategies for inclusion in the GRP, on assigned projects and programs and for securing and alignment on those strategies with the GRL and other key stakeholders.

• Key contributor to development and maintenance of pre-clinical, and both early and late-stage clinical development plans, defining and aligning US strategic considerations with the GRL and project team.

• Provide leadership on project teams and subcommittees in all areas of US regulatory affairs and product development.

• Set US strategic direction and lead US regulatory submission process with submission teams, including marketing applications and core briefing packages.

• Responsible for ensuring the implementation of defined US regulatory strategies, directing organization and preparation of clear and effective US submissions, across all stages of a products life from development through LCM.

• Identify and assess US regulatory risks associated with product development and working with GRL define strategies to mitigate risks identified.

• Direct and oversee US regulatory labelling requirements taking into account reference product, safety, commercial and medical drivers and oversee the implementation to ensure successful execution.

• Oversee the initial set up and management of biosimilar regulatory Ad/Prom vendor for US, partnering closely with internal Ad/Prom teams, to ensure consistent one company approach. Providing vendor oversight on deliverables.

• Monitor and analyze US regulatory policy agenda, with presence on external regulatory committees/trade associations.

• Assess impact of external draft policy on company Biosimilars, co-ordinate input from key stakeholders on regulatory policy agenda for change, and partner closely with internal policy teams to ensure one Biogen voice.

• Foster and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.

• Oversee the set up and management of vendors supporting US regulatory activities, building strong relationships to ensure successful and timely execution of the regulatory deliverables in line with US requirements.

• Mentor and guide team members and/or direct reports in carrying out responsibilities.

• Responsible for defining goals, and career development of direct reports (where applicable).

• Provide input to Regulatory Senior Management teams.

• Prepare and deliver effective presentations for internal and external audience.

qualifications:

• BS degree in pharmacy, chemistry, biology, pharmacology or related life sciences subject is required.

• 8 years pharmaceutical/biotechnology industry experience with technical management

• experience. Minimum of 6 years in US/ Global Regulatory Affairs (Strategy).

• Experience working regulatory aspects of products in pre-clinical and clinical development

• Late-stage development regulatory experience, including leading a significant submission (eg NDA or BLA).

• Direct experience in interfacing with FDA and ability to foster effective, positive interactions with regulatory agencies, and corporate partners.

• Experience in US regulatory pathways for Biosimilars and previous experience in filing Biosimilars preferred but not essential.

• Good knowledge of applicable regulations and experience in interpretation of regulations, guidelines, policy statements, etc.

• Experience and knowledge in the preparation of major US regulatory submissions and supportive

• amendments or supplements.

• Demonstrate excellent leadership and communication skills.

• Ability to lead and influence project teams, committees, etc. to attain group goals.

• Ability to represent the department in project teams, committees, and external meetings to attain group goals and lead teams to success through a motivation for problem solving.

• Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel, including medical, scientific, manufacturing, and corporate partners.

• Take steps to actively improve interdepartmental communications.

• Strong sensitivity for a multicultural/multinational environment. Experience leading multidisciplinary teams.

• Supervisory/mentoring experience, including ability to guide, train, supervise and prioritize workload of direct reports (as applicable).

• Strong capacity for balanced decision making.

skills: Vendor Management, Regulatory Affairs Operations, Submissions

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.