Head of Regulatory Affairs, Bioscience Solutions

Organization
HackEd
Job Location
Walkersville, MD 21703
Job Description

We are seeking a Head of Regulatory Affairs, Bioscience Solutions in Walkersville, Md working at Lanza.

 

Key Accountabilities:

  • Reporting to the Global Head of RA, LPB and based at Walkersville or Basel, the RA Director will support LPB  Bioscience BU and customer related regulatory affairs and CMC project activities.
  • Provide strategic and  technical regulatory leadership, expertise and advice to the Bioscience Business Unit and related internal  and external customers
  • Leads  professional RA staff in field of expertise across the Lonza network
  • Develops and maintains high level contacts with external RA stakeholders including customers, regulatory authorities, academic institutions, scientific experts in regulatory and toxicology
  • Develops and maintains relationships among the Lonza worldwide RA function
  • Provides RA input into Business Unit Strategy
  • Anticipation, evaluation and Influencing (both internal and external) of global regulatory trends and legislation                                                                                                        
  • Work collaboratively with appropriate company personnel to co-ordinate the regulatory work stream elements for Bioscience products. This will include:
    • Preparation and review of scientific and technical information. 
    • Regulatory strategy for medical devices, DMFs and all communication on such matters with regulatory authorities
    • Scientific advice meetings and regulatory strategy

 

  • Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions
  • Management of the  regulatory team covering Bioscience  functions.
  • Internal regulatory support for the operation and control of the Bioscience BU.
    • Interpretation of applicable EU, US and other global regulatory requirements
    • Act as regulatory contact in all direct communication with regulatory agencies
    • Foster good relationships with EU and US regulatory bodies.
    • Support site specific regulatory documents and activities
    • Update Business Units, site and functional leads and maintain transparency of information across regulatory function.
    • Regulatory support for deviation and change control activities, as appropriate.
    • Act as the BU lead for all regulatory affairs activities

 

  • Maintain documented regulatory project plans in line with agreed best practice  
  • Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the LPB  RA team.

 

Requirements

 

Required Qualification (Education/Experience):

  • Post-graduate qualification in biological sciences, chemistry, biochemistry  or equivalent education and at least 10 years experience in industry with current and  proven experience in submission and approval of EU and US medical devices.
  • Bachelor's degree in biological sciences, chemistry, biochemistry  or equivalent education and at least 15 years experience in industry with current and proven experience in in submission and approval of EU and US medical devices.

 

Functional Knowledge:

  • At least 10 years industry experience of which at least six should include recent and demonstrable regulatory affairs experience in submission and approval of EU and US Medical  Devices and related product safety.
  • Expertise in the interpretation and communication of CMC regulatory requirements for site product and process issues.
  • Knowledge of US and EU regulatory requirements for biological and ATMPs
  • Ability to interpret compliance requirements for the creation or review of protocols and site documentation. 
  • Understands Regulatory and  Industry trends across all areas of GXP to anticipate the needs of both the company and the customers and communication of these trends.
  • Proven recent experience of preparing and authoring complex regulatory submissions for medical devices and biological products
  • Proficient with Microsoft Office products;
  • Superb organizational skills and attention to detail and ability to manage multiple project timelines.

 

Problem Solving Skills:.

  • Able to work in a fast paced diverse environment to obtain solutions based on a solid background and understanding of the company procedures, regulatory guidance, current legislation and company and customer objectives.

 

Interpersonal Skills:

  • Able to communicate a site regulatory compliance philosophy internally and to clients.
  • Excellent communication and interpersonal skills; detail  orientated.
  • Demonstrated ability to work collaboratively with cross functional teams.
  • Fluent in English. Second language an advantage.
  • Willingness to travel

 

Skills and Competencies:.

  • Ability to review and critique complex technical documents.
  • Strong influencing skills, making timely decisions using relevant  data; ability to  work with different audience levels
  • Strategic and systematic approach toward goals and objectives with the ability to overcome challenges
  • Strong customer focus, gaining insight of and understanding customer requirements.
  • Excellent leadership skills, organizational capability and ability to foster opportunities for talent development.
  • Ability to challenge the status quo and foster change.

Strong interpersonal skills and ability to interact positively with all functions able to represent the company on regulatory issues internally and externally •        

How to Apply

send resume, name and job title to sherita.smaw@hackeducate.com

 

DO NOT APPLY ON THE WEBSITE UNTIL RESUME IS REVIEWED.

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