Director, Regulatory Affairs, Mena Region

2 days ago

المملكة العربية السعودية, Saudi Arabia BeiGene Full time

General Description:
The MENA Regulatory Affairs Director will report to the MENA regional General Manager. The role will be responsible for developing and implementing MENA regulatory strategies for development programs to secure and maintain marketing authorization for products in line with business objectives, and in coordination with key internal stakeholders. The role will work closely with the BeiGene’s global & regional New Markets regulatory teams.

Essential Functions of the job:

- Develop MENA regulatory strategy for the designated projects, and contribute to the clinical development plans, especially for projects at early development stage
- Contribute to the relevant global teams, sub-teams and working teams, and lead the regulatory strategic projects in MENA, as required.
- Assist in the preparation, writing and review of regulatory documents, and briefing documents for interactions with MENA regulatory authorities, including preparing responses to questions
- Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of submissions and timely approvals
- Oversee and be accountable for regulatory agencies/bodies communications, submissions, and approvals, with a quality focus to secure first-cycle/attempt approvals
- Responsible for all local post marketing regulatory obligations
- Maintain up-to-date working knowledge of laws, regulations, and guidelines across the MENA regulatory authorities.
- Represent the BeiGene MENA regulatory function at industry consortium (maybe required)
- Liaise with other line functions, e.g legal, compliance, QA, CMC, Operations and Ad/Promo/Labeling groups to ensure compliance and business continuity
- Lead and mentor team members

Education Required:

- Bachelor’s degree of pharmaceutical sciences or an equivalent degree

Computer Skills: Efficient in Microsoft Word, Excel, and Outlook

Other Qualifications:

- Minimum of 10+ years’ experience in the biotechnical or pharmaceutical industry, and a minimum of 8+ years’ experience in a Regulatory capacity with a broad background.
- Experience working with the different MENA regulatory procedures is mandatory for this role.
- Sound understanding of the drug development process, the pharmaceutical industry and healthcare environment including Global, EU and MENA regulatory requirements and policy trends
- Recent experience with oncology products and CTAs, MAAs, ODD, PIP is preferred
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- Proven ability to facilitate interactions with Global Regulatory Affairs, other departments within BeiGene and external parties
- Arabic native speaker with high level proficiency in handling communications in English and remote working possible

Supervisory Responsibilities:
Travel: 25% of time

Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and b

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