Associate Director, Regulatory Affairs – Remote Based

Carlsbad, California | Full-Time

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Within Greenwich Biosciences s/he contributes to the company’s overall success by interpretation, development and advancement of policy objectives, strategies and tactics in line with business goals.

 

Key Responsibilities/Accountabilities

  • Lead and support for regulatory policy and strategy activities for the US region, including co-ordination of reviews, information gathering, provision of technical input and attendance at industry and 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 policy activities to ensure appropriate focus.
  • Lead and drive 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 life-cycle 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 participates in and contributes to outside relevant industry meetings, conferences and forums including organizing and delivering presentations.
  • Update regularly senior leadership team members. Provides direction and makes operational decisions on specific policy matters in combination with other senior management team members. Makes presentations to executive level colleagues.

 

Detailed Responsibilities/Accountabilities

  • 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 leadership on specific policy issues for relevant project teams, with an inclusive global approach as required.
  • Act as company representative on specific trade associations, 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 leadership and direction as it relates to US policy and intelligence.
  • Acts as deputy to Senior Director – Global Regulatory Policy and Compliance when required.
  • 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.

 

Key Attributes/Skills/Education - Essential

  • 14 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 organisation.
  • 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 organisation 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 distill complex issues into succinct summaries that clearly convey the specific impact to the company.
  • Demonstrates a strong ability to identify, analyse 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.
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
  • Job Type
  • Attractive
  • Associate
  • Degree Preferred
  • 7-10 Years
  • Full-Time
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