Regulatory Affairs Senior Manager

Carlsbad, California | Full-Time

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We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.

About The Role

The Senior Manager role manages and supports the business of the company specifically in respect to US regulatory policy and more generally in respect to global regulatory policy and intelligence. S/he will contribute to the company’s overall success by interpretation, development and advancement of policy objectives, strategies and tactics in line with business goals.

Responsibilities

  • Support for regulatory policy and strategy activities for the US region, including coordination of reviews, information gathering, provision of technical input and attendance at working group meeting as required to influence outcomes to benefit company strategy and position Greenwich Biosciences as a leading pharmaceutical company in cannabis science.
  • Provide regular communication to the US region and broader company on US regulatory policy and intelligence activities to ensure appropriate focus.
  • Help manage engagement for policy recommendations and advocacy strategies to decrease the hurdles to US and global development of Greenwich Biosciences product programs as well as to the lifecycle management of commercial products.
  • Liaise with US regulatory product teams and government affairs to provide knowledge of emerging regulatory trends and intelligence to improve product speed to market.
  • Effect strategies and approaches to aid generation of US and global positions, influencing plans and internal communications including connection of internal subject matter experts on key US regulatory policy issues.
  • Actively supports and contributes to outside relevant industry meetings, conferences and forums.
  • Update regularly senior leadership team members. Provides support and input to operational decisions on specific policy matters in combination with other senior management team members. Supports and presents, as required to executive level colleagues.
  • Monitoring the US regulatory landscape to review and shape strategy and policy activities to position Greenwich Biosciences at the forefront amongst other cannabis companies.
  • Communicate impact and bring awareness of business-critical US policy issues for informed decision making and work with regulatory team, subject matter experts within the company to assess impact on Greenwich Biosciences products and goals.
  • Provides assessment and impact analysis on specific policy issues for relevant project teams, with an inclusive global approach as required.
  • Act as company representative on specific trade associations as and when required e.g. BIO.
  • Work in collaboration with US regulatory affairs as regulatory local policy contact.
  • Provides information/input/reports to the global regulatory policy and compliance lead as required.
  • Looked upon as a subject matter expert in their field and provides support and direction as it relates to US policy and intelligence.
  • Participate in regulatory processes and initiatives e.g. continuous improvement.
  • Travel: General travel assumption – 30% local (Carlsbad, DC), 10% international (UK - Cambridge, Sittingbourne).
  • Note: This job description describes the principal and main elements of the role. It is a guide to the nature and main duties of the job as their currently exist but is not intended as a wholly comprehensive or permanent schedule.
     

 

Required Experience

 

  • 12 years+ pharmaceutical regulatory strategy/policy experience.
  • Relevant degree in a life sciences discipline.
  • Demonstration of strong communication and influencing skills both within and outside the organization.
  • Demonstration of a deep functional knowledge of the US external regulatory environment and currency in the field of US policy.
  • Proven experience with engagement and relationship building with regional/local Health Authorities and trade associations.
  • Clear understanding of the broader operation of the pharmaceutical organization and the partner disciplines to regulatory.
  • Ability to manage risk and escalate issues when appropriate.
  • Knowledge and experience in interpretation of US/International guidance, regulations, policy statements etc.
  • Requires excellent written and oral communication skills and an ability to distil complex issues into succinct summaries that clearly convey the specific impact to the company.
  • Demonstrates a strong ability to identify, analyze and solve problems.
  • Able to facilitate discussions with groups with diverse backgrounds and help drive decisions.
  • Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.
  • Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
  • Proven ability for optimism and energy in the face of change and adversity.
  • Proven ability to manage projects across global locations/time zones.

Join Us!

Greenwich Biosciences / GW Pharmaceuticals
Greenwich Biosciences / GW Pharmaceuticals
HQ: Carlsbad, California

GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise.

Company size: 900

  • Salary
  • Career Level
  • Degree
  • Experience
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  • Attractive
  • Full-Time
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