25 Nov '20
Regulatory Affairs Manager (11month contract)

Medical, Gauteng Gauteng

Market - Related

A global pharmaceutical company is seeking a Regulatory Manager (11 month contract) to be responsible for new registrations and existing registrations maintained in accordance with the current requirements of the various Health Authorities in Africa.

Advance Pipeline/Marketed Product Support: Submissions, Renewals & Approvals:

  • Ensure that all regulatory submissions (new applications and variations) are prepared, filed and approved in a timely manner to meet business targets covering all products in country. Work with agents in country to gain speedier approvals of new applications.
  • Maintain all existing pharmaceutical product marketing authorisations and gain regulatory
  • Authority approval for the variations of these authorisations. Work with agents in country to gain speedier approvals of variations.
  • Keep abreast of emerging legislation, guidelines in Nigeria, Ghana, Mauritius and highlight the potential impact on the business.
  • Maintain licences in Kenya, Uganda, Zimbabwe, Ethiopia, Tanzania and any GMP licence (Region Africa) in product portfolio
  • Update RA activities in Launch excellence and ensure on time documentation of submissions and approvals in regulatory systems.
  • Review and update package inserts in line with CCDS requirements ensuring an end to end process which includes MOH submission and approval, translations, systems documentations, GLS, awareness at the affiliate and Change control in PPLS.
  • Creation, proof-reading and approval of country labeling text, mock-ups, artworks in PPLS.
  • Notify immediately of awareness of any regulatory requests, including safety labelling changes, urgent safety restriction requests, as well as external inspections.
  • Support regulatory colleagues when necessary

 

Compliance/Training:

  • Ensure compliance with statutory local, regional, and corporate regulations
  • Provide technical support to Affiliate Safety Representative (ASR) in submitting PSURs if necessary
  • Maintain all regulatory trackers for product and country portfolio to ensure real time monthly updates
  • Review and approve local promotional material from Regulatory perspective and in line with the South African Marketing Code and registered prescribing information.
  • Communication of regulatory submissions and approvals via regulatory systems;
  • Manage CCDS database for product portfolio.
  • Manage label change control database for PPLS and provide monthly reports on status.
  • Provide Launch Excellence Tool support for portfolio of products to the brand teams.

 

Regulatory Excellence:

  • ­Cooperate and liaise with manufacturing sites, corporate head-office and other AFFILIATE departments.
  • ­Coordinate and ensure effectiveness of Regulatory Affairs function.
  • ­Write BOP in line with Global Policies, procedures and local procedures.
  • ­Assist in BOP development, review and initiation in line with Global Policies, procedures and local procedures in line with Global Policies, procedures and local procedures.

 

Transforming the Organisation: FutureFit/LRP:

  • ­Participate in local brand teams to assist with product development and project planning to ensure that the proposed development plans account for regulatory requirements and that clinical advice is available throughout the process.
  • ­Support business development on the market.
  • ­Coordinate activities that assist product areas by providing support for:
  • Sales and Marketing
  • Product complaints and liabilities, where necessary
  • Medical support and information (e.g. provide explanation on SmPC when needed) to sales force, customers and end users.

 

General Responsibility:

  • To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the company
  • Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent schedule.

 

Accountability:

  • Responsible for presentation and accuracy of documentation submitted to regulatory authorities.
  • This is a position in which, with appropriate supervision, a significant level of autonomy is anticipated along with project responsibility.
  • Accountable to Regulatory Affairs and Quality Assurance Director – South Africa and Region Africa.

 

Education

  • Bachelor of Pharmacy degree (or equivalent qualification).
  • Tertiary courses in Medicine Registration, Advertising Medicines and other related subjects.
  • Literacy in the following software packages: Lotus Notes, Microsoft Office
  • Tertiary qualification in a management discipline an advantage

 

Knowledge

  • Knowledge of current legislation governing product registration
  • Knowledge of other legal requirements impacting the regulatory environment e.g. advertising, Good Manufacturing Practice (GMP) etc.
  • Knowledge of pharmacology and therapeutic areas
  • Knowledge of the organisation, policies and procedure

 

Experience

At least five years’ experience in the regulatory affairs environment

 

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

 

Ad Visible Until: 5 February 2021
Ref: CPT000107/CH

Vacancy Type: Permanent