Technical & Regulatory Affairs Manager

All vacancies of AustraliaHealthcare & MedicalTechnical & Regulatory Affairs Manager

The Technical & Regulatory Affairs Manager is responsible for all technical and regulatory aspects of Medreich Australia Pharmaceutical portfolio

Summary about this job

Pharmaceuticals & Medical Devices

Company: Medreich Australia

Location: Sydney

Work type: Full Time

Salary: $120,000 - $139,999

Phone: +61-7-9865-5863

Fax: +61-2-1700-7888

E-mail: n\a

Site:

Detail information about job Technical & Regulatory Affairs Manager. Terms and conditions vacancy

About the business and the role

  • We are fully integrated pharmaceutical company with an established presence across the globe. The company is involved in the manufacturing of pharmaceutical preparations in various dosage forms catering to diverse Therapeutic categories across various geographies. 
  • The Australian business was established in 2005 and today has over 200 skus with large customer base of MN's companies
  • The Australian office is a team of five and is located in Homebush
  • Head office, manufacturing and R&D facilities located in India 
  • The role has a strong focus on the Technical and Quality activities and is responsible for all and technical aspects of Medreich Australia Pharmaceuticals products portfolio, ensuring compliance with the TGA, Medsafe, GMP, pharmaceutical and manufacturing standards.You will use your technical expertise to coordinate and submit licenses and authorisations to support optimal timelines for new/modified OTC and Prescription products.
  • This role will add value to the business through the delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence, excellence in execution and building strong relationships with key internal and external stakeholders. As a result, we are looking for a highly resilient, dynamicand adaptable individual who has the ability to manage multiple stakeholder relationships.

  • Must have current NSW drivers licence and own car for customer meetings

 

 

Job tasks and responsibilities

Technical

  • Act as a single point of contact with knowledge of the ANZ Chemical Manufacturing Controls (CMC) regulatory requirements. 
  • Participate in cross-functional project teams and work effectively with multiple disciplines and personalities while ensuring cross-functional alignment on regulatory strategies
  • Perform and support quality activities related to the importation, repackaging, release, storage and distribution of the company's products
  • Support quality activities and resolve quality issues timely to ensure continuous provision of quality compliant product
  • Ensuring technical compliance with global manufacturing facilities
  • Assess the regulatory impact on manufacturing and quality changes
  • Maintain close liaison with production and packaging sites to ensure adherence to standards. Maintain appropriate records for future reference
  • Provide technical assistance to management in all quality and related activities
  • Review and report deviation fault analysis and manage escalation process
  • Participate in and make contribution to new product launch projects
  • Broad understanding of pharmaceutical manufacturing, change control, and global distribution systems
  • Liaise with other functions as necessary (e.g. pharmacovigilance)
  • Provide training/guidance to QA associate as required

Regulatory Affairs

  • Responsible for the overall regulatory strategy through discussion/input from the Business Unitand other departments
  • Responsible for managing third party agencies assisting with Regulatory Affairs activities. This includes the budget for the use of such services
  • Assist with the preparation of regulatory submissions for new products or product information changes as required by the Company strategy or Regulatory Authorities
  • Providing strategic advice and direction to the Global management team
  • Ensure the registration and compliance of locally marketed products throughout their lifecycle
  • Maintain all of the company's license applications
  • Analyse the scientific content of selected new registration packages to ensure they comply with government regulations prior to submission
  • Keep up-to-date with government legislation as it relates to regulatory affairs
  • May take a leadership role in updating and preparing the Company for minor changes in ANZ legislations
  • Ensure regulatory issues with business impact are communicated and documented, in a concise, accurate and timely manner

 

 

Skills and experience

Education / Qualifications / Experience:

  • Australian Permanent resident or citizen
  • A degree in a scientific discipline 
  • Extensive pharmaceutical industry experience in Regulatory Affairs and Technicalwithin the Australian and New Zealand context, preferably in a similar role(minimum 3yearsof experience in regulatory affairs).
  • Must have experience in preparing submissions for OTC and Prescription (generic) medicinesand variationchanges for the TGA.
  • Demonstrated strong technical expertise working with the TGA and Medsafe. Experience working in the TGA is highly regarded.

Skills:

  • Excellent written and verbal communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with internal and external stakeholders
  • Advanced project management skills 
  • Strong telecommunication skills, with the ability to interact with local and global colleagues over a teleconference
  • Robust knowledge and commitment to comply with relevant rules and regulations, whilst maintaining high level of scientific quality and integrity

 

 

 

 

Job benefits and perks

  • Some domestic and international travel required
  • Petrol card
  • Dedicated car space
 

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