Senior Regulatory Affairs Manager

Main purpose:

• Manage Regulatory Affairs activities for Tunisia for assigned AbbVies product portfolio and Represent RA AbbVie on all Tunisia Brand Teams to ensure all existing and new products comply with government standards and business priorities
• Represent RA AbbVie in front of distributors Trade associations and local government bodies
• Supervise Eye Care & Aesthetics portfolio across NWA : 3 countries
• Manage 1 Regulatory member Regulatory Affairs Specialist NWA

Main Responsibilities

REGULATORY AFFAIRS

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

• Keep abreast of emerging legislation local or international related to registration and pharmacovigilance and highlight the potential impact on the business.
• Develop lead drive the Tunisia regulatory strategy in line with business priorities after aligning with NWA RA Director and ensure the implementation.
• Keep and establish smooth relationships with regulatory agency for regulatory affairs including registration renewal variations pricing vigilance and inspection-licensing for effective and timely market all products.
• Provide guidance on the approval processes to marketing colleagues in the Tunisia and regulatory input for launch planning.
• Work with Global and local teams thus ensuring local needs are considered in Global/Regional regulatory strategies which support the strategic planning process local inputs to dossier development and product owner for pharmaceutical products.
• Support the registration of complex applications including but not limited to new products in accordance with relevant legislation and guidelines so that appropriate patient and business outcomes are achieved.
• Contribute to broader operational strategic discussions with brand team and area that impact the business.
• Gather a thorough knowledge of the registration files and all related company product documentation. Keep up to date on Company products.
• Provide Regulatory support in defining and implementing local strategy within the assigned portfolio.
• Work with the demand and marketing departments for proper Business Case Form preparation.
• Review and sign-off registration packages prior to submission to ensure compliance with local and corporate requirements.
• Ensure that all Regulatory submissions (new marketing authorisation applications renewals variations notifications) are prepared and filed in a timely manner for Company products marketed and/or registered in Tunisia or new products intended to be marketed Follow up all steps for authorisation/approval of these submissions.
• Gain Regulatory Authority approval for marketing authorisations for new products.
• Maintain all existing product marketing authorisations and gain Regulatory Authority approval of variations (amendments) to these authorizations as required.
• Manage any further information requests from local Regulatory Authority in a timely manner ensuring local authoritys expectations are accurately translated for AbbVie Area Regulatory. Submission of any subsequent responses/product documentation updates to local Regulatory Authority.
• Review Product Information in accordance with legal and regulatory requirements; ensure that all prescribing information is accurate updated and approved by both Company and relevant Regulatory Authority in accordance with Company policies and local regulations.
• Work closely with logistics department to organize timely sample delivery
• Coordinate with Labelling packaging projects strategy and implementation within agreed timeframe including development with third parties of updated artwork for cartons labels and leaflets in accordance with Company requirements and local regulations for all products.
• Co-ordinate handling of company core date sheet (CCDS) updates for all products.
• Keep accurate records of all health authority correspondence as well as key internal communications and review promotional material foe compliance with relevant laws guidelines codes of conduct and policies.
• Review and approve local promotional material from regulatory perspective.
• Set registration strategy for Eye Care & Aesthetics pipeline including Pharma products & medical devices

• Work closely with internal stakeholders:
  • Logistics department to organize timely sample delivery
  • The demand and marketing departments for proper Business Case Form preparation and coordinate with Area to get endorsement
  • Market Access team to ensure price submission and approval for all new and registered products
  • Labelling to supervise packaging projects strategy and implementation within agreed timeframe including development with third parties of updated artworks for cartons labels and leaflets in accordance with company requirement and local regulations

Team Leadership: supervise and mentor a direct report (Regulatory Affairs Specialist NWA) providing guidance feedback and support to foster their professional development conduct performance evaluations and identify training needs.

Regulatory Excellence:

• Represent AbbVie in the relevant pharmaceutical trade associations and liaise with external stakeholders as appropriate.
• Represent the organization in matters before regulatory legislative or industry standards agencies so the organizations interests are advanced.
• Establish and maintain good relationship with all involved regulatory institutions in Tunisia.
• Identify and track changes/trends in the authorisation practice and attitudes in Tunisia and communicate them within the Company in order to monitor and forecast regulatory environment as needed.
• Oversee the most difficult complex or large application processes so the application has higher chances to be successful.
• Ensure the effectiveness of Regulatory Affairs function in Tunisia.
• Support NPI/Launch Excellence process in Tunisia

Compliance/Training:

• Ensure compliance with AbbVies corporate policies procedures and guidelines as well as with local regulations to meet statutory quality and business requirements within the overall strategy and objectives of Tunisia.
• Be the support function within Tunisia for Regulatory training and other Regulatory-related activities.
• Has accountability for the function in Tunisia and provides the highest level of advice and recommendations on company regulatory compliance.

Transforming the Organisation:

• Participate in local brand teams to assist with new product development and strategic project planning to ensure that the proposed development plans account for regulatory requirements and that clinical advice is available throughout the process.
• Develops and implements the regulatory affairs strategy that aligns with both business needs and global goals and vision and its current and long-term business objectives. Ensures that all activities and programs are implemented in accordance with the organizations strategy.
• Support business development on the market.
• Coordinate activities that assist product areas by providing support to all required functions
• Monitor regulatory developments in Tunisia and advise appropriate stakeholders on the potential impact of regulations on the organization.

People/Talent:

• Lead Supervise and co-ordinate activities of direct report(s) ensuring that a strategic direction is provided and that team members have specific goals packages in place and that they are reviewed formally once per year and informally on a quarterly basis
• Ensure Training of Tunisia staff on relevant Regulatory process
• Develop a team of professionals to ensure the organizations regulatory affairs activities are conducted accurately ethically and according to relevant regulations laws and standards.

General Responsibility:

To comply with the companys policies and procedures to meet statutory quality and business requirements within the overall strategy and objectives of AbbVie Tunisia.

Qualifications :

Background:

• Strong leadership and management skills
• Minimum of (7) years of experience in a multinational Tunisia pharmaceutical environment with a strong experience in the Tunisian Market and understanding global (EU and US)) Regulatory Affairs requirements.
• Ability to think strategically in all aspects of incumbents areas of responsibility. Able to see the big picture and how tasks fit into the overall business and /or product strategy.
• Able to negotiate and collaborate effectively/ good team player and to work in a cross functional matrix environment.
• Able to identify and anticipate trends in Tunisia Regulatory affairs environment and to lobby on behalf of AbbVie in influencing regulatory policy and outcomes.
• Fluency in English both verbal and written efficient Computer Skills.
• Thorough attention to details and high standards of accuracy
• Sound judgment strong communication and negotiating skills

Education:

Education: University degree in Bachelor of Pharmacy

Additional Information :

Internal Stakeholders:

Brand Team MKA Business Country Lead Tunisia Brand teams Area and Global RA

External Stakeholders:

Government Regulatory Authorities Distributors in Tunisia & Morocco

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time